FDA Adverse Event
Malfunction
Summary report: N
LEAD MODEL UNKNOWN
MDR report key: 3181932
·
Received June 21, 2013
Report
- Report Number
- 1644487-2013-01875
- Event Type
- Malfunction
- Date Received
- June 21, 2013
- Date of Event
- May 14, 2013
- Report Date
- May 29, 2013
- Manufacturer
- CYBERONICS INC
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PATIENT
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
AN IMPLANT CARD RECEIVED ON (B)(4) 2013 INDICATED THAT THIS VNS PATIENT UNDERWENT LEAD REVISION ON (B)(6) 2013 DUE TO A LEAD DISCONTINUITY. ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 283398 | LEAD MODEL UNKNOWN | LEAD | LYJ | CYBERONICS INC | NI | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 12 YR |