FDA Adverse Event
Malfunction
Summary report: N
PULSE GEN MODEL 102
MDR report key: 1022712
·
Received March 26, 2008
Report
- Report Number
- 1644487-2008-00791
- Event Type
- Malfunction
- Date Received
- March 26, 2008
- Date of Event
- August 1, 2003
- Report Date
- March 13, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
REPORTER INDICATED THAT A VNS PT WAS SCHEDULED TO UNDERGO GENERATOR AND LEAD REVISION SURGERY. FOLLOW UP AFTER THE SURGERY WAS PERFORMED REVEALED THAT ONLY THE GENERATOR WAS REPLACED. FOLLOW UP WITH THE TREATING NEUROLOGIST'S OFFICE REVEALED THAT THE PT HAD PRESENTED WITH HIGH LEAD IMPEDANCE SINCE INITIAL IMPLANTATION. THE PT WAS FINALLY SENT FOR SURGERY AFTER PAINFUL STIMULATION IN THE CHEST WORSENED. DURING SURGERY, THE GENERATOR WAS REPLACED AND THE HIGH IMPEDANCE RESOLVED. THIS LED THE SURGEON TO DETERMINE THAT THE LEAD CONNECTOR PIN WAS NOT FULLY INSERTED INTO THE GENERATOR. ATTEMPTS FOR RETURN OF THE EXPLANTED GENERATOR WERE UNSUCCESSFUL AS THE EXPLANTING FACILITY INDICATED THAT IT WAS DISCARDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 102 | LYJ | CYBERONICS, INC. | 102 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |