FDA Adverse Event
Injury
Summary report: N
INTERSTIM II
MDR report key: 2201760
·
Received August 5, 2011
Report
- Report Number
- 3004209178-2011-06084
- Event Type
- Injury
- Date Received
- August 5, 2011
- Date of Event
- January 1, 2011
- Report Date
- July 12, 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
- TX, 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. THERE WAS NO KNOWN ACCIDENT OR INCIDENT RELATED TO THE EVENT. THE PT WAS NOT ABLE TO FEEL STIMULATION. THE PT RECEIVED ASSISTANCE FROM HER PHYSICIAN AND/OR MANUFACTURER REP ON (B)(6) 2011, AND HER CONCERNS WERE RESOLVED. IT APPEARED THAT THE NEUROSTIMULATOR HAD FLIPPED MULTIPLE TIMES, TWISTING THE LEAD UNTIL THE LEAD BROKE ABOUT 3-4 CM FROM THE NEUROSTIMULATOR. ON (B)(6) 2011, THE NEUROSTIMULATOR LEAD, AND EXTENSION WERE REPLACED. RESULTS WERE PENDING, BUT NO PROBLEMS HAD BEEN OBSERVED. THE PT RECOVERED WITHOUT SEQUELA. THE PT HAD AN APPOINTMENT SCHEDULED FOR (B)(6) 2011.
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 | 64 YR | Required Intervention | IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 3037, LOT# NJD095434N| LEAD: MODEL 3093, LOT# V339438 |