FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM II
MDR report key: 1934478
·
Received November 23, 2010
Report
- Report Number
- 3004209178-2010-09884
- Event Type
- Malfunction
- Date Received
- November 23, 2010
- Date of Event
- January 1, 2010
- Report Date
- November 16, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT AND WAS TOLD THAT HER "WIRE WAS SHORTED OUT". IT WAS NOTED THAT SHE HAD KNEE REPLACEMENT SURGERY ON (B)(6), 2010 BUT THAT THE ISSUE HAD STARTED WELL BEFORE THAT. SHE HAD BEEN REPROGRAMMED TWICE IN THE LAST 2 MONTHS WHICH DID NOT HELP THE ISSUE. ADDITIONAL INFO WAS REQUESTED.
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 | 74 YR | LEAD: MODEL 3093, LOT# V218120| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 3037, LOT# NJD083100N |