FDA Adverse Event
Malfunction
Summary report: N
PULSE GEN MODEL 101
MDR report key: 1012712
·
Received March 11, 2008
Report
- Report Number
- 1644487-2008-00674
- Event Type
- Malfunction
- Date Received
- March 11, 2008
- Date of Event
- February 1, 2008
- Report Date
- February 12, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE MALFUNCTION SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.
Description of Event or Problem · 1
INITIAL REPORTER INDICATED THE PT HAD THEIR VNS GENERATOR EXPLANTED FOR LACK OF EFFICACY. GOOD FAITH ATTEMPTS HAVE BEEN MADE FOR PRODUCT RETURN AND INFO ABOUT THE PT'S LACK OF EFFICACY EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 101 | LYJ | CYBERONICS, INC. | 101 | 2132 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |