FDA Adverse Event
Malfunction
Summary report: N
PULSE GEN MODEL 101
MDR report key: 1063532
·
Received June 19, 2008
Report
- Report Number
- 1644487-2008-01425
- Event Type
- Malfunction
- Date Received
- June 19, 2008
- Date of Event
- February 13, 2008
- Report Date
- May 20, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.
Description of Event or Problem · 1
REPORTER INDICATED A PATIENT'S VNS GENERATOR WAS REPLACED BECAUSE IT WAS "NOT WORKING". FOLLOW-UP WITH THE REPORTER REVEALED THE GENERATOR HAD "RUN OUT OF ENERGY". A BATTERY ESTIMATE PERFORMED YIELDED APPROXIMATELY 2.53 YEARS REMAINING ON THE GENERATOR; HOWEVER, OVER A YEAR OF PROGRAMMING HISTORY WAS MISSING. ADDITIONAL ATTEMPTS TO THE REPORTER ARE IN PROGRESS.THE EXPLAINTED GENERATOR HAS BEEN RETURNED AND IS CURRENTLY IN PRODUCT ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 101 | LYJ | CYBERONICS, INC. | 101 | 40488C |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 18 YR |