FDA Adverse Event
Malfunction
Summary report: N
PULSE GEN MODEL 101
MDR report key: 1504890
·
Received September 23, 2009
Report
- Report Number
- 1644487-2009-02076
- Event Type
- Malfunction
- Date Received
- September 23, 2009
- Date of Event
- May 19, 2009
- Report Date
- September 16, 2009
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
REPORTER INDICATED, A VNS THERAPY PATIENT UNDERWENT GENERATOR REPLACEMENT SURGERY DUE TO NORMAL END OF SERVICE. THE EXPLANTED GENERATOR WAS RETURNED TO THE MANUFACTURER AND PRODUCT ANALYSIS CONFIRMED THE END OF SERVICE CONDITION. DURING THE ANALYSIS, THE GENERATOR DID NOT MEET THE SPECIFICATION REQUIREMENTS AS THE SUPPLY CURRENT 1MA PARAMETER WAS OVER-THE-LIMIT. THE SUPPLY CURRENT 1MA PARAMETER OVER-THE-LIMIT CURRENT CONSUMPTION CONDITION COULD POTENTIALLY BE A CONTRIBUTING FACTOR TO THE END-OF-SERVICE; HOWEVER, ANALYSIS OF THE DEVICE DETERMINED THAT THE END-OF-SERVICE CONDITION WAS EXPECTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 101 | LYJ | CYBERONICS, INC. | 101 | 435 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 16 YR |