FDA Adverse Event
Malfunction
Summary report: N
PULSE GEN MODEL 101
MDR report key: 1203394
·
Received October 15, 2008
Report
- Report Number
- 1644487-2008-02501
- Event Type
- Malfunction
- Date Received
- October 15, 2008
- Date of Event
- January 1, 2008
- Report Date
- October 7, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT A VNS PATIENT UNDERWENT GENERATOR REVISION SURGERY. THE EXPLANTED GENERATOR WAS RETURNED TO THE MANUFACTURER. PRODUCT ANALYSIS REVEALED THAT THE GENERATOR WAS AT END OF SERVICE. DURING ANALYSIS, THE POST BURN-IN-ELECTRICAL TEST RESULTED IN AN OVER-LIMIT SUPPLY CURRENT PULSING MEASUREMENT. A LEAKY TRANSISTOR Q9 WAS IDENTIFIED AS THE CAUSE. HOWEVER, THE DEFECTIVE Q9 DID NOT IMPACT DEVICE PERFORMANCE, AND ONLY HAD A MINIMAL IMPACT ON THE BATTERY LONGEVITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 101 | LYJ | CYBERONICS, INC. | 101 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39 YR |