FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM
MDR report key: 5070287
·
Received September 11, 2015
Report
- Report Number
- 3004209178-2015-17781
- Event Type
- Malfunction
- Date Received
- September 11, 2015
- Report Date
- August 13, 2015
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3095-10, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3889-28, LOT# V001614, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. (B)(4)
Description of Event or Problem · 1
IT WAS REPORTED THAT FOUR OF THE PATIENT LEADS WERE NOT WORKING. THE HEALTHCARE PROVIDER LATER REPORTED THAT THE PATIENT HAD NOT BEEN SEEN AT THEIR OFFICE SINCE SURGERY (B)(6) 2006.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 604083 | INTERSTIM | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 3023 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00061 YR |