FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM II
MDR report key: 2924618
·
Received January 22, 2013
Report
- Report Number
- 3004209178-2013-00802
- Event Type
- Malfunction
- Date Received
- January 22, 2013
- Report Date
- January 2, 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
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT PRODUCTS: PRODUCT ID 3093-28, LOT# V054682, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID 3093-28, LOT# V017147, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3037, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT A BATTERY DEPLETED NOT VERY LONG AFTER THE PATIENT GOT IT PUT IN, AND THE PHYSICIAN RECOMMENDED PLACING TWO BATTERIES AT THE REVISION. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THE IMPLANT DID NOT WORK FOR THEM AND THE BATTERY DIED AND WAS REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 29468 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 3058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |