FDA Adverse Event
Malfunction
Summary report: N
KINETRA
MDR report key: 1061530
·
Received June 17, 2008
Report
- Report Number
- 9614453-2008-03268
- Event Type
- Malfunction
- Date Received
- June 17, 2008
- Date of Event
- February 1, 2008
- Report Date
- May 17, 2008
- Manufacturer
- MEDTRONIC SWISS MANUFACTURING FACILITY
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Removal / Correction Number
- Z-0693-2008
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
UPON RECEIPT, THE DEVICE WAS FOUND IN A NO OUTPUT / NO TELEMETRY CONDITION. FURTHER ANALYSIS REVEALED BROKEN BOND WIRES CONNECTING THE BATTERY TO THE HYBRID CIRCUIT. THE EPOXY BOND BETWEEN THE HYBRID AND BOTH BATTERY TERMINALS WAS BROKEN. THE BATTERY STATUS WAS 2.64 VOLTS.
Description of Event or Problem · 1
IT WAS REPORTED INTERMITTENT POWER ON RESETS HAD OCCURRED SEVERAL TIMES DURING PROGRAMMING SESSIONS IN 2008. EVENTUALLY TELEMETRY WAS NO LONGER POSSIBLE; THE NEUROSTIMULATOR STOPPED FUNCTIONING. NO PATIENT INJURY WAS REPORTED. THE DEVICE WAS REPLACED. THE PATIENT'S THERAPY RESUMED AFTER REPLACEMENT.
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 |