FDA Adverse Event
Injury
Summary report: N
INTERSTIM II
MDR report key: 2936126
·
Received January 30, 2013
Report
- Report Number
- 3004209178-2013-01157
- Event Type
- Injury
- Date Received
- January 30, 2013
- Report Date
- January 14, 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
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID, 3889-28 LOT# V011108, IMPLANTED: 2006 (B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 3037 LOT# SERIAL# (B)(4), IMPLANTED: 2006 (B)(6), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT 1 TO 2 YEARS PRIOR TO THE REPORT, THE DEVICE WAS NOT WORKING BECAUSE OF A "BROKEN" WIRE. NO FURTHER INFORMATION WAS REPORTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 40700 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 3058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |