FDA Adverse Event
Injury
Summary report: N
INTERSTIM II
MDR report key: 2946262
·
Received February 6, 2013
Report
- Report Number
- 3004209178-2013-01373
- Event Type
- Injury
- Date Received
- February 6, 2013
- Report Date
- January 16, 2013
- 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
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID 3889-28, LOT# V815657, IMPLANTED: 2011-(B)(6), PRODUCT TYPE LEAD PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT AN IMPLANTABLE NEUROSTIMULATOR (INS) WAS REMOVED. IT WAS UNCLEAR WHY THE INS WAS REMOVED. THE REPORTER STATED THAT THE DEVICE LEAD WAS FRAYED, BUT WAS UNSURE IF IT WAS REMOVED. 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 |
|---|---|---|---|---|---|---|---|
| 50720 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 3058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |