FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM II
MDR report key: 2558943
·
Received May 3, 2012
Report
- Report Number
- 3004209178-2012-02964
- Event Type
- Malfunction
- Date Received
- May 3, 2012
- Report Date
- April 9, 2012
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- PATIENT FAMILY MEMBER OR FRIEND
Narratives
Additional Manufacturer Narrative · 1
LEAD MODEL 3093-33, LOT # V851923, IMPLANTED: (B)(6) 2012, EXPLANTED: NA.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT WAS UNABLE TO ADJUST STIMULATION. IT WAS DISCOVERED THAT THE NEUROSTIMULATOR WAS POWERED OFF. THE PATIENT'S INS WAS AT PROGRAM 1 AT 4.2 VOLTS, BUT THE INS WAS OFF. STIMULATION WAS DECREASED TO 1.0 VOLTS AND THEN THE INS WAS TURNED ON. THE PATIENT COULD THEN FEEL STIMULATION, WHICH WAS INCREASED TO 1.1 VOLTS. 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 |