INTERSTIM
Report
- Report Number
- 3004209178-2013-06654
- Event Type
- Injury
- Date Received
- April 22, 2013
- Report Date
- April 16, 2013
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
(B)(4).
PRODUCT ID: 3889-28 LOT# V515942, IMPLANTED: 2010 (B)(6), EXPLANTED: 2013 (B)(6), PRODUCT TYPE LEAD PRODUCT ID: 3037 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID: 3095-10 LOT# SERIAL# (B)(4), IMPLANTED: 2010 (B)(6), PRODUCT TYPE EXTENSION. (B)(4).
(B)(4).
(B)(4).
(B)(4)
ADDITIONAL INFORMATION STATED THE PATIENT HAD HER LEAD REPLACED IN (B)(6) 2013 AND THE DEVICE WAS NOT EFFECTIVE SINCE (B)(6) 2013. IT WAS NOTED THE PATIENT WAS CONSTIPATED FOR A WHILE AND WAS NOT ANYMORE, AND WAS GOING TO THE BATHROOM ¿CONSTANTLY.¿ (B)(4).
IT WAS ALSO NOTED THAT THE PATIENT WAS EXPERIENCING A LOSS OF THERAPEUTIC EFFECT. THE PATIENT HAD AT LEAST A 50 % REDUCTION IN FREQUENCY FOR ABOUT A YEAR/YEAR AND A HALF AFTER IMPLANT. THE PATIENT WENT TO HER CHIROPRACTOR IN APPROX THE (B)(6) 2011 AND GOT ADJUSTED. AFTER THAT, THE THERAPY WASN'T EFFECTIVE. THEY HAD ATTEMPTED MULTIPLE TIMES TO CHANGE PROGRAMS. THE PATIENT HAD GONE ON REGIMENS OF TRYING A PROGRAM FOR A COUPLE WEEKS, TRYING ANOTHER PROGRAM, ETC. THE PATIENT HAD A PROGRAMMING VISIT A COUPLE WEEKS PRIOR BUT THERE WAS STILL NO SIGNIFICANT CHANGE. THE PATIENT WAS GOING 'TEN TIMES A NIGHT'. THEY HAD LOOKED FOR UTIS BUT THE PATIENT WAS CLEAR. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.
IT WAS REPORTED THAT ON (B)(6) 2013, THE PATIENT HAD HER LEAD REPLACED. THE PATIENT WASN'T SURE EXACTLY WHY, BUT NOTED THAT THE HEALTH CARE PROVIDER BELIEVED IT 'WASN'T WORKING RIGHT'. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.
IT WAS LATER REPORTED THAT THEY REPLACED THE LEAD TO TRY AND GAIN EFFICACY. ALTHOUGH UNSURE, THE MANUFACTURER'S REPRESENTATIVE BELIEVED THE OLD LEAD WAS LEFT IN THE BODY. THEY HAD DONE SEVERAL CONFIGURATIONS OF PROGRAMMING. THE REPORTER FELT THAT THE PATIENT HAD SLIGHT IMPROVEMENT. THEY WERE TRYING TO MANAGE THE PATIENT'S EXPECTATIONS ON WHAT IS EFFECTIVE THERAPY. IT WAS FELT THAT THE PATIENT MIGHT HAVE A MISUNDERSTANDING IF SHE DOESN'T GET 100% RELIEF TO THINK THAT IT ISN'T WORKING. THE PATIENT WAS PRE-DIABETIC AND DRINKS A LOT OF SODA, JUICE,AND COFFEE WHICH SHE SHOULDN'T BE. THE PATIENT CAME FROM A DIFFERENT OFFICE SO THE REPORTER HAD NO BASELINE TO COMPARE TO. THEY WERE HAVING THE PATIENT TURN THE DEVICE OFF FOR TWO DAYS AND TAKE A DIARY AND THEN TURN IT ON FOR TWO DAYS AND TAKE A DIARY SO THEY CAN GAIN A BASELINE TO WORK FROM.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS TIRED OUT BECAUSE IT HAD JUST BEEN SO LONG SINCE THEY HAD ACTUALLY HAD SLEEP WITHOUT ALL THE DISRUPTIVE GOING TO THE BATHROOM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 172463 | INTERSTIM | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 3023 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00073 YR | Required Intervention |