FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM II
MDR report key: 2904270
·
Received January 9, 2013
Report
- Report Number
- 3004209178-2013-00356
- Event Type
- Malfunction
- Date Received
- January 9, 2013
- Report Date
- December 18, 2012
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- EZW
- PMA / PMN Number
- P080025
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID 3889-28, LOT # VA01FG5, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).
Description of Event or Problem · 1
WHEN CONTACTED FOR FOLLOW UP INFORMATION, THE PHYSICIAN HAD NOT SEEN THE PATIENT SINCE 6 WEEKS POST FOLLOW UP. THE PATIENT HAD NOT CALLED THE PHYSICIAN REGARDING THE EVENT. ATTEMPTS BY THE PHYSICIAN TO GET IN TOUCH WITH THE PATIENT BY PHONE WERE UNSUCCESSFUL. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT SNEEZED AND "GOT A SHOCKING IN HIS BALLS" WHICH WAS PAINFUL. NO FURTHER INFORMATION WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 12931 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 3058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |