FDA Adverse Event
Malfunction
Summary report: N
LEAD MODEL UNKNOWN
MDR report key: 2211088
·
Received August 5, 2011
Report
- Report Number
- 1644487-2011-01796
- Event Type
- Malfunction
- Date Received
- August 5, 2011
- Date of Event
- July 6, 2011
- Report Date
- July 6, 2011
- Manufacturer
- CYBERONICS INC
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
- Health Professional
- Yes
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT'S VNS DEVICE WAS SHOWING HIGH LEAD IMPEDANCE. THERE IS NO KNOWN CAUSE OF THE HIGH LEAD IMPEDANCE, BUT THE PT DID HAVE A RECENT GENERATOR REPLACEMENT DUE TO END OF SERVICE, SO THERE IS QUESTION THAT IT COULD BE A PIN INSERTION ISSUE, THOUGH THIS IS NOT CONFIRMED. THE PT WAS SEEN BY A SURGEON AND IT WS RECOMMENDED THAT THE PT UNDERGO FULL REVISION SURGERY, THOUGH THIS HAS NOT OCCURRED TO DATE. ATTEMPTS FOR FURTHER INFO HAVE BEEN UNSUCCESSFUL TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LEAD MODEL UNKNOWN | LYJ | CYBERONICS INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Male |