FDA Adverse Event
Injury
Summary report: N
INTERSTIM II
MDR report key: 2231105
·
Received August 26, 2011
Report
- Report Number
- 3004209178-2011-06938
- Event Type
- Injury
- Date Received
- August 26, 2011
- Date of Event
- August 3, 2011
- Report Date
- August 15, 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
- ME, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT WAS NOT ABLE TO ADJUST THE STIMULATION, BOTH WITH AND WITHOUT THE ANTENNA ATTACHED, USING THE PT PROGRAMMER. THE IMPEDANCE READINGS AND BATTERY WERE CHECKED AND THERE WERE NO PROBLEMS. IT WAS REPORTED THAT THE PT EXPERIENCED A LACK OF BENEFIT AND "LEAKAGE." A LEAD REVISION WAS, THEREFORE, PERFORMED. A NEW LEAD WAS PLACED ON THE SIDE OF THE PT'S BODY OPPOSITE THE PLACEMENT OF THE PREVIOUS LEAD. THE PT WAS NOT HOSPITALIZED AND THERE WAS NO INJURY TO THE PT. THE PT WAS SUBSEQUENTLY, "DOING GREAT."
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 | 36 YR | Required Intervention | EXPLANTED:| IMPLANTED:| LEAD: MODEL 3093, LOT# V292727| PROGRAMMER: MODEL 3037, LOT# NJD088968N |