FDA Adverse Event
Injury
Summary report: N
INTERSTIM II
MDR report key: 3362335
·
Received September 23, 2013
Report
- Report Number
- 3004209178-2013-16742
- Event Type
- Injury
- Date Received
- September 23, 2013
- Report Date
- August 30, 2013
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID: 3093-33, LOT# V926210, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. (B)(4).
Description of Event or Problem · 1
2013-08-30 CRTS 2991657 (CON): IT WAS REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS TO BE EXPLANTED AT A FUTURE DATE DUE. THE PATIENT WAS NO LONGER HAVING BLADDER ISSUES AND HAD NOT USED STIMULATION IN A YEAR. IT WAS STATED THAT THE INS WAS SO UNCOMFORTABLE THAT HE HAD AN APPOINTMENT TO GET IT REMOVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 479711 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 3058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |