FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM II
MDR report key: 2541189
·
Received April 19, 2012
Report
- Report Number
- 3004209178-2012-02493
- Event Type
- Malfunction
- Date Received
- April 19, 2012
- Report Date
- March 31, 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
- PA, US
- Reporter Occupation
- PATIENT FAMILY MEMBER OR FRIEND
Narratives
Additional Manufacturer Narrative · 1
(B)(4): LEAD MODEL 3889-28, LOT# V926179, IMPLANTED: 2012-(B)(6), EXPLANTED: NA; PROGRAMMER MODEL 3037, SERIAL# (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT FELT NO STIMULATION SENSATION. THE SETTINGS ON PROGRAM 1 WERE CHANGED FROM 0.5 VOLTS TO 1.2 VOLTS, BUT THAT WAS TOO STRONG SO THE SETTINGS WERE CHANGED TO PROGRAM 1 AT 1.1 VOLTS. THE PATIENT COULD FEEL STIMULATION WELL IN HER PELVIC FLOOR AREA AND IT WAS NOT UNCOMFORTABLE. IT WAS ALSO REPORTED THAT THE PATIENT FELT LIKE STIMULATION WAS TURNING OFF INTERMITTENTLY, BUT IT WAS NOT CONFIRMED IF STIMULATION WAS ACTUALLY SHOWING OFF ON THE PATIENT PROGRAMMER WHEN THIS OCCURRED. 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 |
|---|---|---|---|---|---|---|---|
| 1 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 3058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |