FDA Adverse Event
Injury
Summary report: N
INTERSTIM II
MDR report key: 1910085
·
Received November 24, 2010
Report
- Report Number
- 3004209178-2010-09943
- Event Type
- Injury
- Date Received
- November 24, 2010
- Date of Event
- January 5, 2010
- Report Date
- November 18, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT'S NEUROSTIMULATOR AND LEAD WERE EXPLANTED DUE TO INFECTION AND "SPONTANEOUS EXPULSION". THE PT WAS REPORTED AS "UNHARMED". 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 | 84 YR | Required Intervention | IMPLANTED:| LEAD: MODEL 3889, LOT# V209962| PROGRAMMER: MODEL 3037, LOT# NJD082445N| EXPLANTED: |