Fda Release 2/28/2007

[tigger_gal]

http://www.accessdata.fda.gov/script...FOI__ID=741793


Adverse Event Report
MED REL, JUNCOS INTERSTIM IPG back to search results

Model Number 3023
Event Date 06/22/2005
Event Type Other Patient Outcome Death; Other
Event Description
The manufacturer was notified on june 29, 2006, that the following event is now a legal file. The patient underwent placement of a stage i interstim system as an outpatient on june 22, 2005. Shortly thereafter, she was found to be unresponsive. Autopsy report indicated the cause of death to be cardiomegaly and the manner of death to be natural.


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Brand Name INTERSTIM
Type of Device IPG
Manufacturer (Section F) MED REL, JUNCOS
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777

Manufacturer (Section D) MED REL, JUNCOS
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777

Manufacturer (Section G) MED REL, JUNCOS
road #31 km 24 hm 4,
ceiba norte industrial park
juncos PR 00777

Manufacturer Contact marie holm
4000 lexington avenue north
shoreview , MN 55126
(800) 328 -0810

Device Event Key 729640
MDR Report Key 741793
Event Key 706887
Report Number 3004209178-2006-1224
Device Sequence Number 1
Product Code GZB
Report Source Manufacturer
Source Type Other
Reporter Occupation Physician
Remedial Action Other
Type of Report Initial
Report Date 06/29/2006
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received 07/27/2006
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL Number 3023
Device Catalogue Number 3023
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received 06/29/2006
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? Yes
Is this an Explanted Device? No Answer Provided
Type of Device Usage Initial

Database last updated on February 28, 2007

Product Classification Database
Device stimulator, spinal-cord, implanted (pain relief)
Regulation Description Implanted spinal cord stimulator for pain relief.
Regulation Medical Specialty Neurology
Review Panel Neurology
Product Code GZB
Submission Type 510(k)
Regulation Number 882.5880
Device Class 2
GMP Exempt? No
Third Party Review Not Third Party Eligible
Database Updated 3/07/2007

[Sarojini]

Interesting. However, it sounds like the manner of death really had nothing to do with the Stim and is reported as due to natural causes -- the woman had cardiomegaly, which is an enlargement of the heart which often goes undiagnosed until autopsy.

However, because she had the Interstim, it had to be reported to the company and to the FDA. This goes back to what I was saying once before -- with all medical studies, and with all medical devices, ANY deaths of patients in the study or with the device must be reported to the FDA and the device manufacturer.

However, it sounds like the family of the woman is suing... I wish them luck, but cardiomegaly is usually genetic and doesn't have anything to do with an InterStim. The only thing I can think of is that since the anesthesiologist did not know about the cardiomegaly, the doses of anesthesia caused the death.

[tigger_gal]

Yes, I understood it as you did, but it is saying if you have this condition you are not a candidate for the stim surgery, or any surgery.

[Sarojini]

That's correct

[DebbieB]

Very Interesting Cindy !!!

In this person case any kind of surgery , having cardiomegaly would have been the same out come , it is to bad that the doctor that was doing this or anesthesiologist have known this and it could of been avoided !!

Debbie

[tigger_gal]

diffently.. I just wanted everyone to see this, so if they are considering getting the stim they need to tell their doctor about it.