FDA Adverse Event
Malfunction
Summary report: N
LEAD MODEL 302
MDR report key: 2023427
·
Received March 8, 2011
Report
- Report Number
- 1644487-2011-00441
- Event Type
- Malfunction
- Date Received
- March 8, 2011
- Date of Event
- February 8, 2011
- Report Date
- March 14, 2018
- Manufacturer
- CYBERONICS INC
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 1
DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY.
Description of Event or Problem · 1
RPTR INDICATED A VNS PT HAD HIGH LEAD IMPEDANCE WITH VNS DIAGNOSTICS. THE VNS WAS DISABLE. X-RAYS WERE PERFORMED WHICH DID NOT INDICATE ANY OBVIOUS ANOMALIES PER THE RPTR. THE PT HAS HAD NO TRAUMA AND DOES NOT MANIPULATE THE VNS. VNS REVISION SURGERY IS PLANNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LEAD MODEL 302 | LYJ | CYBERONICS INC | 302-20 | 009894 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 13 YR | Male |