FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL 102
MDR report key: 1002553
·
Received February 26, 2008
Report
- Report Number
- 1644487-2008-00382
- Event Type
- Injury
- Date Received
- February 26, 2008
- Date of Event
- January 28, 2008
- Report Date
- January 29, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE MALFUNCTION IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.
Description of Event or Problem · 1
THE REPORTER INDICATED THE PT HAD A REVISION SURGERY DUE TO GENERATOR MIGRATION. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFO ARE IN PROGRESS AND AWAITING RESPONSE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 102 | LYJ | CYBERONICS, INC. | 102 | 015852 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Hospitalization |