Contact Information for Neuromodulation Division

Anonymous

Guest
Can any one help me to find the name and contact number for the VP of sales for the Neuromodulation division?
Better yet how can I find out what practitioners use the Boston Scientific SCS and DBS units.

December 17, 2014
To: Daniel C. Gerhan, Senior Litigation Counsel, Boston Scientific Corporation
From: Benjamin H. Ghanoongooi
Re: Response to Your Invitation to Contact You, Regarding Defective, Unsafe Medical Devices, Which Are Being Manufactured By Boston Scientific Corporation, Neuromodulation, Valencia, California

Dear Mr. Gerhan:
Thank you, for your invitation to contact you, and the opportunity to address the issue that defective, unsafe medical devices are being manufactured by Boston Scientific Corporation, Neuromodulation, Valencia, California. The SPINAL CORD SIMULATOR (SCS) AND DEEP BRAIN SIMULATOR (DBS) UNITS, which have been and are being manufactured by Boston Scientific Corporation, are not safe, and have the potential to cause patient injury, long-term disability, and possibly, a fatality. THE CHARGER AND THE UNIT ARE DEFECTIVE. The only hardware related to the Unit that does not have an issue is the remote. (The remote is NOT manufactured by Boston Scientific Corporation.)
This is my first correspondence to you, so there is information that I need to share with you. I have fourteen (14) years of experience in Quality Management for Medical Device Manufacturing and Sterilization, from inception to completion of medical devices, which includes RESEARCH AND TESTING.
As Quality Manager, at Parter Sterilization Services, in 2005, I, Benjamin H. Ghanoongooi, designed the “original” Boston Scientific/Advanced Bionics, Sterilization Cycle Specification. When I was designing the cycle, I discovered that there was an issue with the Simulator Leads, THEN…THAT STILL EXISTS, TODAY.
I have also been a Senior Sterilization Specialist for Medtronic, Incorporation, from 2005-2011, and a Senior Sterility Engineer, Neuromodulation, for Boston Scientific, Corporation, from 2011 through Friday, November 14, 2014.
PLEASE NOTE: I have not violated the Boston Scientific Corporation, Code of Conduct or violated my employment contract, during my term of employment, at Boston Scientific Corporation (Neuromodulation).


You, Sir, have been given inaccurate information, and been misinformed, with regard to my removal of documents from my workplace at Neuromodulation, Valencia. (In fact, please find attached an E-mail, from October 20, 2014, when this same line was run, and I was not even at work, nor had been, since September 19, 2014.) There were Forty-three (43) IPG’s not able to be found. It was alleged, if you will, that I was the last person who had them in my possession – get this, in February, 2014. I was able to QUICKLY DISPEL this “suggestion” that I knew anything about the 43 missing IPG’s by promptly providing the receipt of acceptance, signed by Jessica Lee, Manager II, Quality, on February 21, 2014.

QUESTION 1: WHERE WERE THE FORTY-THREE (43) IPG’S, FROM FEBRUARY 21, 2014, UNTIL MONDAY, OCTOBER 20, 2014?

QUESTION 2: WHY SHOULD “I” KNOW WHERE THEY WERE, SINCE JESSICA LEE, MANAGER II, QUALITY, ACCEPTED, AND SIGNED FOR THEIR RECEIPT ON FEBRUARY 21, 2014?

QUESTION 3: SHOULDN’T THE PERSON WHO SIGNED FOR THE FORTY-THREE (43) IPG’S “KNOW” WHERE THEY ARE?

QUESTION 4: WHY WAS THE “CASE OF THE (43) MISSING IPG’S” INTRODUCED THE VERY “NEXT” BUSINESS DAY, “AFTER” I HAD JUST MET WITH SENIOR MANAGEMENT REGARDING MY CONCERNS?

QUESTION 5: WHY WAS THIS “URGENT” SEARCH FOR THE (43) MISSING IPG’S DONE, WHEN I WAS ABSENT, AND HAD NOT BEEN AT WORK FOR MORE THAN FOUR (4) WEEKS OR AT MY CUBICLE OR DESK, WHICH IS “WHERE THE FOCUS OF THE SEARCH FOR THE (43) MISSING IPG’S TOOK PLACE?

PLEASE FURTHER NOTE: The afore-described situation occurred on Monday, October 20, 2014, the Monday, after the Friday, October 17, 2014, ONE OF THE MANY TIMES that I made my concerns known to Senior Management!

By profession, I am a mechanical engineer. I have United States Governmental Clearance, since I have been commissioned to participate in U.S. Military, National Defense and National Security Projects. I am also an Acceptance Agent for The United States Department of Treasury. Truthfulness, following the rules, and choosing to do the right thing, because it is the right thing to do – Is who I am; and what I do.

THEREFORE, I HAVE A REASONABLE AND LOGICAL QUESTION – WHAT WOULD OR COULD I DO WITH FORTY-THREE (43) USED, DEFECTIVE IPG’S? PERHAPS, YOUR ANSWER WILL HELP ME TO BETTER UNDERSTAND.


In response to your statement that I removed documents from my workplace at Neuromodulation, Valencia, AS THE DESIGNER OF THE STERILIZATION CYCLE, I do not have, nor do I need documents from Boston Scientific Corporation. WHO BETTER THAN I, WOULD KNOW MORE ABOUT THE INITIAL PHASES OR STERILIZATION TEST RESULTS REGARDING LEADS THAN I? I have my 14 years of experience, knowledge, and test findings, in my memory and recall to give me the confidence and the ability to not allege that the medical devices that are being manufactured by Boston Scientific Corporation, Neuromodulation, Valencia, California, are defective, but I can, and do assert that the entire Unit, except for the remote is defective.

• Allege – To affirm without necessarily being able to prove.
• Allegation – An assertion or statement yet to be proved.
• Assert – To state as true, maintain, insist on.
• Assertion – A positive statement.

Therefore, I assert, and CAN PROVE without reservation that The SPINAL CORD SIMULATOR (SCS) AND DEEP BRAIN SIMULATOR (DBS) UNITS, which have been and are being intentionally manufactured by Boston Scientific Corporation, (Neuromodulation, Valencia, California) are defective, and are not safe, and have the potential to cause patient injury, long-term disability, and possibly, a fatality. THE CHARGER AND THE UNIT ARE DEFECTIVE.

The statement that I just made about Boston Scientific’s product is not false, as you propose, in your E-mail to me, dated December 15, 2014.

• False – Untrue, wrong, incorrect, mistaken
• True – In agreement with fact

As defined, to assert is to state as true. My findings are based on the results and outcome of such testing, regardless of who conducts it – or under whatever circumstances. Regardless of whether “any” Corporation designs a “similar product”, “with identical factors”, based on the research and findings, it will result in a “similar defective, unsafe product” as that which has been and is being manufactured by Boston Scientific Corporation (Neuromodulation).

The statement previously made, and this communication about Boston Scientific’s product is not defamatory.
Defame/defamatory – To attack the good character or reputation of someone.

My intention has never been to defame or to attack the good character or reputation of Boston Scientific Corporation (Neuromodulation). However, I have tried numerous times, and in numerous ways to initiate a dialogue regarding omitted Corporate and regulatory Non-conformities, and my defective product/patient safety concerns.
I would like to see Boston Scientific Corporation “fix” its defective and unsafe product issue, because it is the right thing to do – not because they were “forced” by legal or regulatory bodies that imposed penalties, because of violations for not acting in good faith, with regard to the design and development of quality medical devices.
It has always been my concern that Senior Management at Boston Scientific Corporation would choose to do the “right thing”, and resolve the issues with the Simulator Leads, which I discovered, when I was designing the cycle, in 2005. As I stated before, there was an issue with the Simulator Leads then that still exists, today.
Please understand that there are Boston Scientific Neuromodulation personnel with knowledge that there are quality product and patient safety concerns regarding the defective traits exhibited with ALL Neuromodulation manufactured product. I still have the same concerns now, that I had nine (9) years ago. Unfortunately, the matter has not been resolved, and requires more attention now, than then.
Again, with regard to who knew or knows what -- In 2011, now, more than three (3) years ago, when I became a Boston Scientific employee, I expressed my concerns about the ineffectiveness of the Simulator Leads. Then, and for all practical matters, now, I can seem to get no one to confer with me, and TAKE THIS MATTER SERIOUSLY, and UNDERSTAND that there are concerns with the Simulator Leads that have the potential to cause patient injury, long-term disability, or, God forbid, a fatality. The matter is just that serious!
The issue with my concerns regarding the Simulator Leads is NOT a new issue. In 2011, I raised issues and concerns about the ineffectiveness of the Simulator Leads. That same year, 2011, I was given the assignment by my supervisor, Mr. Ali Nejat, Manager II, Quality Control, to write an evaluation of the Simulator Leads; respectively, the 32 Contact Paddle Qualification (Sterilization Qualification), and 1 x 16Y Lead Sterilization Evaluation. Obviously, my assessment for the evaluation was not compatible with what Mr. Ali Nejat, Manager II, Quality Control, expected or wanted it to be.

I discussed with my Supervisor, Mr. Ali Nejat, Manager II, Quality Control, my concerns, and that what I was proposing for my assessment was what I knew factually about Simulator Leads, from my own personal experience. Mr. Najat reprimanded me harshly, and indicated that I did not know how to write the report, and gave the assignment to someone else. Ali Nejat, Manager II, Quality Control, never wanted to talk to me specifically about Simulator Leads, after that experience.
The fact of the matter was not that I did not know “how” to write the assessment or evaluation, but rather, “what” I was writing. My assessment and evaluation was NOT “favorable”, with regard to information that I was to provide, in the evaluation, since I was not comfortable making an assessment, based on my prior knowledge.
PLEASE NOTE AND BE ADVISED: Now, here we are a few days away from 2015, with the same Simulator Leads concerns, as those that I brought to the attention of my Supervisor, Mr. Ali Nejat, in 2011. The fact of the matter that still stands is that nothing has changed. The medical devices manufactured by Boston Scientific Corporation (Neuromodulation, Valencia, California) are defective, and are unsafe for patient use.
My primary concern has been, and is, patient safety.
As long as Boston Scientific Corporation (Neuromodulation) does not correct its defective product/patient safety issues, it will not be I, who make less favorable the Corporation’s good name or its reputation, but the Boston Scientific Corporation, itself. The longer it takes for Senior Management to engage in meaningful, constructive communication with me, the more people are subject to liability –including you, Mr. Gerhan.
At this point, and under these circumstances relative to this discourse and disclosure, Boston Scientific Corporation’s Management, and anyone and everyone else, especially those who are involved in or with the manufacturing, marketing/sales, implantation, advocating of this defective, unsafe product, or those who have utilized the product in the past, or are currently implementing the product, cannot say that they were not put on notice that the SPINAL CORD SIMULATOR (SCS) AND DEEP BRAIN SIMULATOR (DBS) UNITS, which have been and are continuing to be intentionally manufactured by the Boston Scientific Corporation (Neuromodulation) are defective, and unsafe for patient use.



ALL PARTIES HAVE BEEN PUT ON NOTICE OF THE DEFECTIVE AND UNSAFE PRODUCT, WHICH HAS QUALITY AND PATIENT SAFETY ISSUES, and is being manufactured by Boston Scientific Corporation (Neuromodulation) Valencia, California. When a product is manufactured under the conditions in which the defective, unsafe product in question is manufactured, one will ALWAYS get a defective, unsafe product. BOTTOM LINE!
With regard to your request for the return of the Boston Scientific-issued Laptop Computer, following my discharge on November 14, 2014, as I am so obligated, I have initiated contact with the Department of Justice and Homeland Security to provide me with instructions as to where and how I am to arrange for pick-up of the Boston Scientific-issued laptop. These two agencies were contacted on December 16, 2014, after having received your communication. Whichever contacts me first, is the set of instructions that I will follow for the prompt return of the Boston Scientific-issued laptop. The following paragraphs will explain.
On September 18, 2014, per the written communication and request of Mrs. Jean F. Lance, Senior Vice President and Chief Compliance Officer, I was instructed to meet with Mrs. Lynn Prust, Director of Employee Relations, and Mr. Tom Landon, Regional Security Manager (Western Region), on September 19, 2014. The purpose of the meeting was to bring to their attention my concerns, with regard to the violations of the Boston Scientific Code of Conduct, by Senior Vice President of Quality, Mr. Patrick Crotteau, and Mr. Albert D. Candioty, Director, Process Development.
Upon the initiation of the meeting, I requested authorization from Mr. Tom Landon, Regional Security Manager (Western Region), to insert an external flash drive into the Boston Scientific-issued laptop, in order to provide to them several personal and confidential Government-issued credentials and documents issued to me, which establish my credibility as well as the seriousness of my concerns. Mr. Tom Landon asked whether the external flash drive contained a virus, and my reply to Mr. Landon was no.
Not taking into consideration that such would be the case, files that were opened, and information that was shared with Mrs. Lynn Prust, Director of Employee Relations, and Mr. Tom Landon, Regional Security Manager (Western Region) were imaged onto the hard drive, in the Boston Scientific-issued laptop.
*** (Please check with Mr. Tom Landon, Regional Security Manager (Western Region), for verification of this scenario.)

As I prepared to respond to your request for the return of the laptop, I remembered the occasion on which I had opened these files. Realizing such, I knew that I needed to find out the appropriate protocol for me to return the laptop, and not just put it in the FedEx box provided to me, for return to Boston Scientific, considering the fact that the laptop now contains classified and sensitive information pertaining to the National Security of the United States. As I stated, I have contacted The Justice Department and Homeland Security to get answers, so that the Boston Scientific-issued laptop may be returned. Upon notification by either Department, I will promptly contact you, with information, regarding same.
However, as you indicated return of the Boston Scientific-issued laptop, to be effectuated by Friday, December 19, 2014, by 5:00 PST, this may not be possible; depending upon whether I receive an answer from the Justice Department or Homeland Security, today or tomorrow, with instructions for return of your property.
In this regard, please feel free to do whatever you feel is necessary for you to do, with regard to the matter of the return of the laptop, or for any other matter that you feel warrants taking further actions. Please feel free to contact me, at any time, for further exchange on any of the matters herein discussed. Thank you.

Respectfully submitted,


Benjamin H. Ghanoongooi
 






I'm assuming no one bothered to reply to you, since this isn't Boston Scientific thread. And FYI- Boston Scienfic doesn't do DBS in the US. It's Medtronic until last week and now STJ too