FDA Adverse Event
Malfunction
Summary report: N
LEAD MODEL 302
MDR report key: 3910757
·
Received July 2, 2014
Report
- Report Number
- 1644487-2014-01677
- Event Type
- Malfunction
- Date Received
- July 2, 2014
- Date of Event
- June 9, 2014
- Report Date
- June 9, 2014
- Manufacturer
- CYBERONICS INC
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DEVICE MANUFACTURING RECORDS WERE REVIEWED. REVIEW OF MANUFACTURING RECORDS CONFIRMED THAT THE LEAD PASSED ALL FUNCTIONAL TESTS PRIOR TO DISTRIBUTION. 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 PRIOR TO GENERATOR REPLACEMENT SURGERY ON (B)(6) 2014 DUE TO ERI, THE VNS PATIENT¿S DEVICE SHOWED HIGH IMPEDANCE. THE PATIENT¿S LEAD WAS ALSO REPLACED DURING THE PROCEDURE. THE SURGEON DID NOT OBSERVED ANY BREAKS ON THE EXPLANTED LEAD. THE EXPLANTED GENERATOR AND LEAD HAVE NOT BEEN RETURNED TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 386614 | LEAD MODEL 302 | LEAD | LYJ | CYBERONICS INC | 302-20 | 008902 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 27 YR |