FDA Adverse Event
Injury
Summary report: N
INTERSTIM
MDR report key: 3502251
·
Received December 5, 2013
Report
- Report Number
- 3004209178-2013-22010
- Event Type
- Injury
- Date Received
- December 5, 2013
- Report Date
- November 15, 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
- NV, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID 3093-28 LOT# V250970, IMPLANTED: 2009 (B)(6); PRODUCT TYPE LEAD. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT SINCE IMPLANT, THE PATIENT FELT A ¿BEATING SENSATION¿ IN HIS TESTICLES 6 TIMES EVERY MINUTE. IT WAS STATED THAT THE SENSATION WAS ANNOYING AND THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS NOT FUNCTIONING, SO IT WAS REMOVED 3 TO 4 YEARS AGO.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 630526 | INTERSTIM | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 3023 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00079 YR | Required Intervention |