FDA Adverse Event
Malfunction
Summary report: N
LEAD MODEL 302
MDR report key: 4152795
·
Received October 8, 2014
Report
- Report Number
- 1644487-2014-02591
- Event Type
- Malfunction
- Date Received
- October 8, 2014
- Date of Event
- September 8, 2014
- Report Date
- September 8, 2014
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NM, US
- Reporter Occupation
- PHYSICIAN
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
ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE VNS PATIENT UNDERWENT GENERATOR AND LEAD REPLACEMENT SURGERY ON (B)(6) 2014 DUE TO LEAD DISCONTINUITY. THE GENERATOR WAS REPLACED PROPHYLACTICALLY. THE EXPLANTED DEVICES HAVE NOT BEEN RETURNED TO DATE.
Description of Event or Problem · 1
IT WAS REPORTED THAT DEVICE DIAGNOSTICS RESULTED IN HIGH IMPEDANCE (>10,000 OHMS). IT WAS REPORTED THAT THE LAST KNOWN GOOD DIAGNOSTICS WAS A YEAR PRIOR. IT WAS REPORTED THAT THE DEVICE WOULD BE PROGRAMMED OFF AND THE PATIENT WOULD BE REFERRED FOR SURGERY. NO SURGICAL INTERVENTIONS HAVE BEEN PERFORMED TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 630764 | LEAD MODEL 302 | LEAD | LYJ | CYBERONICS, INC. | 302-20 | 008950 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 20 YR |