FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM
MDR report key: 1180991
·
Received September 29, 2008
Report
- Report Number
- 3004209178-2008-06188
- Event Type
- Malfunction
- Date Received
- September 29, 2008
- Date of Event
- August 1, 2008
- Report Date
- September 2, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT BUMPED HER IMPLANTABLE NEUROSTIMULATOR ON THE CORNER OF A TABLE LAST WEEK. SHE HAD "BUMPS" UNDER THE SKIN OVER THE INS SITE. THE INS SITE WAS VERY TENDER BUT NOT WARM. SHE WAS UNSURE IF THERE WAS ANY SKIN COLOR CHANGE. SHE ONLY COULD FEEL STIMULATION ON THE LEFT SIDE OF HER BODY. THE STIMULATION DID NOT FEEL AS STRONG AND HER SYMPTOMS HAVE INCREASED SLIGHTLY. FURTHER INFORMATION IS BEING REQUESTED FROM THE HCP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERSTIM | EZW | MEDTRONIC PUERTO RICO OPERATIONS CO. | 3023 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | EXPLANTED:| PROGRAMMER: MODEL 3031A| IMPLANTED:| LEAD: MODEL 3889 LOT# V001996| EXPLATNED:| IMPLANTED:| EXTENSION: MODEL 3095 |