FDA Adverse Event
Malfunction
Summary report: N
KINETRA
MDR report key: 1032604
·
Received April 22, 2008
Report
- Report Number
- 9614453-2008-02130
- Event Type
- Malfunction
- Date Received
- April 22, 2008
- Date of Event
- February 6, 2008
- Report Date
- March 25, 2008
- Manufacturer
- MEDTRONIC SWISS MANUFACTURING FACILITY
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A F/U REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.
Description of Event or Problem · 1
IT WAS REPORTED THE IMPLANTED NEUROSTIMULATOR STOPPED STIMULATION. NO PT INJURY WAS NOTED. THE DEVICE WAS REPLACED. NO FURTHER PT COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KINETRA | MHY | MEDTRONIC SWISS MANUFACTURING FACILITY | 7428 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |