FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM II
MDR report key: 2191783
·
Received July 22, 2011
Report
- Report Number
- 3004209178-2011-05713
- Event Type
- Malfunction
- Date Received
- July 22, 2011
- Date of Event
- January 1, 2011
- Report Date
- June 28, 2011
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT WHILE STIMULATION WAS TURNED ON THE THERAPY WAS SLIGHTLY HELPING WITH SYMPTOMS. THE RESULTS ARE SIMILAR TO THE PT'S TRIAL. THE ENS STOPPED WORKING DURING THE TRIAL, BUT THE PATIENT FELT THE DEVICE HELPED WITH SYMPTOMS ENOUGH TO GO ONTO IMPLANT. PT WAS CURRENTLY AT 6.3 V AND HAS TRIED TO INCREASE TO 6.6 V BUT THIS HAS CAUSED DISCOMFORT. PT HAD URINARY TRACT INFECTION WHICH STARTED 6 DAYS AGO AND IS NO LONGER PRESENT. ADD'L INFO HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERSTIM II | EZW | MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS | 3058 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 3037, LOT# NJD126715N| LEAD: MODEL 3889, LOT# V625742 |