FDA Adverse Event
Injury
Summary report: N
INTERSTIM II
MDR report key: 2550959
·
Received April 26, 2012
Report
- Report Number
- 3004209178-2012-02718
- Event Type
- Injury
- Date Received
- April 26, 2012
- Report Date
- March 31, 2012
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- EZW
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
LEAD: MODEL 3093-28, LOT# V082173, IMPLANTED: 2008 (B)(6), EXPLANTED: NA. PROGRAMMER: MODEL ID 3037, SERIAL# (B)(4). (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAD A REVISION APPROXIMATELY ONE YEAR AGO WHERE THEY MOVED THE IMPLANTABLE NEUROSTIMULATOR (INS) FROM THE LEFT TO THE RIGHT SIDE OF HER BODY. IT WAS NOTED THAT SIX MONTHS LATER, THE INS WAS NOT FUNCTIONING PROPERLY AT WHICH TIME THE COMPANY REPRESENTATIVE REPROGRAMMED THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MDT PUERTO RICO OPERATIONS CO | 3058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |