FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM II
MDR report key: 3761234
·
Received April 21, 2014
Report
- Report Number
- 3004209178-2014-07555
- Event Type
- Malfunction
- Date Received
- April 21, 2014
- Report Date
- April 1, 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
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3093-28, LOT# V029657, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT HAD BEEN EXPERIENCING A SHOCKING SENSATION FOR THE THREE MONTHS LEADING TO THE CALL. IT WAS NOTED THE PATIENT HAD NO FALLS, ACCIDENTS, OR TRAUMA RELATED TO THE EVENT. IT WAS REPORTED THE PATIENT WAS UNCOMFORTABLE SLEEPING ON THEIR BACK. IT WAS NOTED THE PATIENT FELT THE SHOCKING EVEN IF THEIR STIMULATOR WAS OFF, IF THEY SAT IN A CERTAIN POSITION. IT WAS REPORTED NO IMAGING OR IMPEDANCE CHECKS HAD BEEN PERFORMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 241224 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 3058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00061 YR |