FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM II
MDR report key: 2654993
·
Received July 13, 2012
Report
- Report Number
- 3004209178-2012-05577
- Event Type
- Malfunction
- Date Received
- July 13, 2012
- Report Date
- June 18, 2012
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID 3889-28, LOT# V223166, IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING AN IMPLANTABLE NEUROSTIMULATOR (INS) REPLACEMENT SURGERY THE LEAD'S OUTER SHEATH WAS FOUND TO HAVE BEEN RUBBED OFF FROM RUBBING AGAINST THE INS. IT WAS NOT DUE TO THE REMOVAL OF THE OLD INS. IMPEDANCE MEASUREMENTS WERE CHECKED AND "EVERYTHING WAS FINE." THE PHYSICIAN DID NOT REPLACE THE LEAD.
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 |