FDA Adverse Event
Injury
Summary report: N
INTERSTIM II
MDR report key: 2706592
·
Received August 20, 2012
Report
- Report Number
- 3004209178-2012-07112
- Event Type
- Injury
- Date Received
- August 20, 2012
- Report Date
- July 24, 2012
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). LEAD: MODEL 3093-28, LOT# V863548, IMPLANTED: (B)(6) 2012.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAD PREVIOUSLY HAD A LEAD COME OUT OF THE FORAMEN AND COIL MULTIPLE TIMES. A NEW LEAD AND INS WERE IMPLANTED ON THE OPPOSITE SIDE, AND THE LEAD WAS INSERTED INTO THE FORAMEN. EVERYTHING LOOKED FINE HOWEVER THE PATIENT SUBSEQUENTLY HAD THERAPY COMPLAINTS AND AN X-RAY WAS TAKEN WHICH SHOWED THE LEAD WAS OUT OF THE FORAMEN. IT WAS REPORTED THAT THE HCP WOULD NOT KNOW IF THE LEAD WAS COILED UNTIL HE TRIED TO EXPLANT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 3058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | SEE H10 |