FDA Adverse Event
Malfunction
Summary report: N
PULSE GEN MODEL 102
MDR report key: 1062997
·
Received June 18, 2008
Report
- Report Number
- 1644487-2008-01406
- Event Type
- Malfunction
- Date Received
- June 18, 2008
- Date of Event
- January 1, 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
- IN, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT PATIENT HAD GENERATOR REPLACED DUE TO EARLY BATTERY FAILURE. GOOD FAITH ATTEMPTS WERE MADE WITH THIS PHYSICIAN TO OBTAIN FURTHER INFORMATION SURROUNDING THIS EVENT; HOWEVER, THESE ATTEMPTS WENT UNANSWERED. EXPLANTED GENERATOR WAS RETURNED TO MANUFACTURER AND PRODUCT ANALYSIS IS PENDING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 102 | LYJ | CYBERONICS, INC. | 102 | 009637 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |