FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM
MDR report key: 2770929
·
Received October 3, 2012
Report
- Report Number
- 3004209178-2012-08857
- Event Type
- Malfunction
- Date Received
- October 3, 2012
- Report Date
- September 7, 2012
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID 3889-28, LOT# J0546671V, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID 3095-10, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. PRODUCT ID 3031A, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT WHILE THE STIMULATION WAS TURNED ON, PATIENT FELT STIMULATION INCREASED. PATIENT USUALLY DID NOT FEEL THE STIMULATION. HER SYMPTOMS WERE GOOD AND HAD BEEN WORKING GOOD FOR 6 YEARS. THE IMPLANTABLE NEUROSTIMULATOR WAS EXPECTED TO BE REPLACED NEXT YEAR. PATIENT WOULD TRY TO DECREASE THE STIMULATION WHEN SHE GETS NEW BATTERY FOR HER PROGRAMMER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERSTIM | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MDT PUERTO RICO OPERATIONS CO | 3023 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |