FDA Adverse Event
Malfunction
Summary report: N
LEAD MODEL 302
MDR report key: 3873002
·
Received June 13, 2014
Report
- Report Number
- 1644487-2014-01507
- Event Type
- Malfunction
- Date Received
- June 13, 2014
- Date of Event
- April 11, 2014
- Report Date
- May 16, 2014
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NH, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT'S DEVICE SHOWED HIGH IMPEDANCE. THE DEVICE WAS PROGRAMMED OFF. IT WAS REPORTED THAT THE PATIENT SUFFERED A FALL ON ICE AND WANTS TO WAIT TO HAVE THE DEVICE REPLACED.
Description of Event or Problem · 1
ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE VNS PATIENT¿S DEVICE SHOWED HIGH IMPEDANCE VIA SYSTEM DIAGNOSTICS. THE PATIENT DID NOT EXPERIENCE ANY CHANGE IN SEIZURE CONTROL FOLLOWING THE HIGH IMPEDANCE OBSERVATION. NO KNOWN SURGICAL INTERVENTIONS HAVE OCCURRED TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 349218 | LEAD MODEL 302 | LEAD | LYJ | CYBERONICS, INC. | 302-20 | 009342 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR |