FDA Adverse Event
Malfunction
Summary report: N
PULSE GEN MODEL 102R
MDR report key: 1172155
·
Received September 11, 2008
Report
- Report Number
- 1644487-2008-02207
- Event Type
- Malfunction
- Date Received
- September 11, 2008
- Date of Event
- January 1, 2008
- Report Date
- August 15, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE MALFUNCTION SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH.
Description of Event or Problem · 1
IT WAS REPORTED TO THE MANUFACTURER THAT VNS PATIENT'S DEVICE WAS NOT RESPONDING TO INTERROGATIONS. FOLLOW-UP REVEALED THAT THE LAST TIME THE GENERATOR WAS ABLE TO BE INTERROGATED WAS IN 2008. THE PATIENT REPORTED TO THE PHYSICIAN THAT HE HASN'T FELT STIMULATION IN A WHILE. THE GENERATOR IS SUSPECTED TO BE AT END OF SERVICE BY THE PHYSICIAN, AND REPLACEMENT SURGERY IS BEING SCHEDULED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 102R | LYJ | CYBERONICS, INC. | 102R | 009597 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR |