FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM II
MDR report key: 2961960
·
Received February 14, 2013
Report
- Report Number
- 3004209178-2013-02653
- Event Type
- Malfunction
- Date Received
- February 14, 2013
- Report Date
- January 24, 2013
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
FINAL DEVICE ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (INS) REVEALED THE FOLLOWING: THE #0 CONNECTOR BLOCK WAS NOT COMPLETELY SEATED IN THE INS PORT, CAUSING THE SETSCREW TO BE MISALIGNED WITH THE GROMMET.
Additional Manufacturer Narrative · 1
(B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED THAT A LEAD WAS CONNECTED TO AN IMPLANTABLE NEUROSTIMULATOR (INS) BUT THE SET SCREW WOULD NOT TIGHTEN, IT JUST CLICKED. IT WAS NOTED THAT NO IMPEDANCE COULD BE RUN PROPERLY. A DIFFERENT INS WAS USED AND IT WORKED WELL. THE REPORTER STATED THAT THE PATIENT WAS DOING FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 65081 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 3058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |