FDA Adverse Event
Injury
Summary report: N
INTERSTIM II
MDR report key: 2220234
·
Received August 16, 2011
Report
- Report Number
- 3004209178-2011-06396
- Event Type
- Injury
- Date Received
- August 16, 2011
- Date of Event
- January 1, 2011
- Report Date
- July 21, 2011
- 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
- SC, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) TURNED SIDEWAYS ABOUT ONE YEAR AGO AND CAUSED DISCOMFORT. IT HURT MORE WHEN THE PT WAS IN A SEATED POSITION. THE PT ALSO EXPERIENCED A BLADDER INFECTION WHICH CLEARED UP RECENTLY. THE PT REPORTED 50% RELIEF, BUT REPORTED SHE DID NOT FEEL A STIMULATION SENSATION. THE PT UNDERWENT TWO REVISIONS, ONE DUE TO THE INS MOVEMENT AND ONE DUE TO A LEAD BREAK.
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 | 75 YR | Required Intervention | IMPLANTED:| LEAD: MODEL 3093, LOT# V267033| EXPLANTED:| PROGRAMMER: MODEL 3037, LOT# NJD087784N |