FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM II
MDR report key: 2920931
·
Received January 17, 2013
Report
- Report Number
- 3004209178-2013-00725
- Event Type
- Malfunction
- Date Received
- January 17, 2013
- Report Date
- December 28, 2012
- 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
- SC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3093-28, LOT# V813549, IMPLANTED: (B)(6) 2011. PRODUCT TYPE: LEAD: PRODUCT ID 3037, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT A PATIENT WAS HAVING TROUBLE INCREASING STIMULATION. IT WAS NOTED THAT THE DEVICE WAS OFF. IT WAS REPORTED THAT THE PATIENT WAS SURPRISED AND SHOCKED BY THE DEVICE WHEN SHE TURNED IT ON. THE PATIENT TURNED DOWN THE STIMULATION AND RESOLVED THE FEELING OF OVERSTIMULATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 27096 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 3058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |