FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM II
MDR report key: 3693488
·
Received March 21, 2014
Report
- Report Number
- 3004209178-2014-04835
- Event Type
- Malfunction
- Date Received
- March 21, 2014
- Report Date
- February 26, 2014
- 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
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT: PRODUCT ID 3037, SERIAL#(B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. PRODUCT ID 3 889-28, LOT# V872659, IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT FELT AN INCREASE IN STIMULATION SENSATION WHEN USING BONE GROWTH STIMULATOR. IT WAS NOTED THE PATIENT COULD TOLERATE THE INCREASED SENSATION. IT WAS REPORTED THE MANUFACTURER REPRESENTATIVE WAS TO MEET WITH THE PATIENT UPON COMPLETION OF THE BONE GROWTH STIMULATION THERAPY. IT WAS NOTED THE PATIENT WAS RECEIVING EFFECTIVE THERAPY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 168682 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 3058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00074 YR |