FDA Adverse Event
Malfunction
Summary report: N
LEAD MODEL 302
MDR report key: 1040828
·
Received May 9, 2008
Report
- Report Number
- 1644487-2008-01105
- Event Type
- Malfunction
- Date Received
- May 9, 2008
- Date of Event
- January 1, 2008
- Report Date
- April 1, 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
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 1
DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY.
Description of Event or Problem · 1
IT WAS REPORTED TO MFR THAT THE VNS PT WAS HAVING SURGERY DUE TO HIGH LEAD IMPEDANCE. X-RAYS WERE TAKEN AND REVIEWED PRIOR TO SURGERY AND ACCORDING TO THE SURGEON THEY WERE INCONCLUSIVE. DURING SURGERY, THE SURGEON NOTED A LEAD BREAK "AT THE CONNECTOR BOOT AREA." THE SURGEON REMOVED ALL BUT APPROX 2 CM OF THE LEAD. ADDITIONALLY, THE SURGEON WAS NOT ABLE TO IMPLANT A NEW LEAD ON THE LEFT VAGUS NERVE AS THERE WAS "NOT ENOUGH ROOM ON THE NERVE" DUE TO SCAR TISSUE FORMED. A NEW GENERATOR WAS IMPLANTED BUT THE LEAD WAS NOT REPLACED. ATTEMPTS TO OBTAIN ADD'L INFO AND THE EXPLANTED DEVICES FOR ANALYSIS ARE UNDERWAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LEAD MODEL 302 | LYJ | CYBERONICS, INC. | 302-20 | 010850 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 14 YR | Male |