FDA Adverse Event
Malfunction
Summary report: N
BIPOL LEAD MODEL 300
MDR report key: 1810783
·
Received February 29, 2008
Report
- Report Number
- 1644487-2008-00410
- Event Type
- Malfunction
- Date Received
- February 29, 2008
- Date of Event
- January 29, 2008
- Report Date
- January 30, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
CONCLUSIONS: DEVICE MALFUNCTION IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.
Description of Event or Problem · 1
REPORTER INDICATED THAT THE PATIENT'S VNS DEVICE HAS BEEN EXPLANTED. INITIALLY, THE PATIENT WAS SCHEDULED FOR EXPLANT SURGERY DUE TO BATTERY DEPLETION; HOWEVER, TESTING ON THE DAY OF THE REVISION SURGERY REVEALED HIGH IMPEDANCE. THEREFORE, THE SURGEON OPTED TO REMOVE THE GENERATOR AND THE LEAD. EXPLANTED PRODUCTS HAVE BEEN RECEIVED BY THE MFR; HOWEVER, THAT ANALYSIS IS NOT YET COMPLETE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIPOL LEAD MODEL 300 | LYJ | CYBERONICS, INC. | 300-20 | 17255C |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 15 YR | Required Intervention |