FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM II
MDR report key: 1940689
·
Received December 17, 2010
Report
- Report Number
- 3004209178-2010-10573
- Event Type
- Malfunction
- Date Received
- December 17, 2010
- Date of Event
- December 1, 2010
- Report Date
- December 13, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT'S NEUROSTIMULATION DEVICES WERE NOT WORKING AND THAT SHE HAD A LOSS OF THERAPEUTIC EFFECT, SO THE PATIENT TURNED THEM OFF. IT WAS REPORTED THAT THE DEVICES WORKED A LITTLE BIT WHEN THE SECOND ONE WAS IMPLANTED, THEY STOPPED WORKING. IT WAS REPORTED THAT THE DEVICES SOMETIMES ACTIVATED ON THEIR OWN. MULTIPLE SETTINGS WERE TRIED AND THE DEVICES HAD BEEN REPROGRAMMED UNSUCCESSFULLY. THE PATIENT WAS SEEKING A NEW PHYSICIAN AND WAS CONSIDERING HAVING THE DEVICES REMOVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. SEE ALSO MFR # 3004209178-2010-10574.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERSTIM II | EZW | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 3058 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | LEAD: MODEL 3889, LOT# V260968| IMPLANTED:| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 3037, LOT# NJD088062N| IMPLANTED:| PROGRAMMER: MODEL 3037, LOT# NJD068096N| EXPLANTED:| LOT# NJY130920H| IMPLANTED:| LEAD: MODEL 3889, LOT# V100722| IMPLANTABLE NEURO STIMULATOR: MODEL 3058| EXPLANTED: |