FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM
MDR report key: 2190975
·
Received July 19, 2011
Report
- Report Number
- 6000032-2011-05578
- Event Type
- Malfunction
- Date Received
- July 19, 2011
- Date of Event
- June 1, 2011
- Report Date
- December 2, 2016
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO. MED REL
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NOT APPLICABLE
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED ABOUT A YEAR AGO THE PT SAT ON A TV REMOTE CONTROL AND FELT A BURNING SENSATION IN THE AREA OF THE STIMULATOR. WHEN THE STIMULATOR AREA WAS EXAMINED, THERE WAS A HOLE IN THE PT'S PANTS AND THE TV REMOTE CONTROL COVER HAD MELTED. AT THE TIME OF THE EVENT, THE PT WAS PREGNANT, AND THE DEVICE WAS OFF. SINCE THE EVENT, THE PT HAS HAD ISSUES WITH THE DEVICE. ABOUT A YEAR LATER, THERE WAS A LOSS OF THERAPEUTIC EFFECT FOLLOWING A FALL. THE PT FELL TWICE IN THE PAST 2 WEEKS AND HAD A LOSS OF BLADDER CONTROL. THERE WAS ALSO A SURGING SENSATION AND UNCOMFORTABLE STIMULATION. ADD'L INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADD'L INTO BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERSTIM | EZW | MEDTRONIC PUERTO RICO OPERATIONS CO. MED REL | 3023 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 34 YR | Female | Required Intervention | EXPLANTED:| EXPLANTED:| EXPLANTED:| EXTENSION: MODEL 3095 LOT# NAH006746V| IMPLANTED:| IMPLANTED:| IMPLANTED:| LEAD: MODEL 3093 LOT# J0309415V| PROGRAMMER: MODEL 3031A LOT# NGM005247P| PROGRAMMER: MODEL 3031A LOT# NGM005247P| EXTENSION: MODEL 3095 LOT# NAH006746V| EXPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3093 LOT# J0309415V |