FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM II
MDR report key: 3905076
·
Received July 1, 2014
Report
- Report Number
- 3004209178-2014-12321
- Event Type
- Malfunction
- Date Received
- July 1, 2014
- Date of Event
- April 16, 2014
- Report Date
- June 10, 2014
- 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
- MO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3889-28, LOT# VA0H0P7, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD; PRODUCT ID NEU_UN KNOWN_PROG, SERIAL# UNKNOWN, PRODUCT TYPE: PROGRAMMER, PHYSICIAN. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAD THEIR DEVICE IMPLANTED ON (B)(6) 2014 AND NOW THEY HAD TO TURN IT UP EVERY WEEK. THE PATIENT COULD FEEL THE BATTERY MOVING AROUND IN THE POCKET AND WAS IN PAIN AND SOMETIMES THEY DIDN¿T FEEL STIMULATION FROM IT. IT WAS NOTED THAT IT FELT LIKE THE BATTERY HAD MOVED OUT OF THE POCKET.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 384026 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 3058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00045 YR |