FDA Adverse Event
Malfunction
Summary report: N
LEAD MODEL 302
MDR report key: 2241439
·
Received August 18, 2011
Report
- Report Number
- 1644487-2011-01902
- Event Type
- Malfunction
- Date Received
- August 18, 2011
- Date of Event
- July 6, 2011
- Report Date
- July 19, 2011
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- 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 BY A NURSE THAT HIGH LEAD IMPEDANCE WAS RECEIVED DURING AN OFFICE VISIT (7/LIMIT/HIGH/NO). THE PATIENT'S DEVICE WAS DISABLED DUE TO HIGH LEAD IMPEDANCE AND PATIENT DECIDED NOT TO GO THROUGH SURGEON REFERRAL FOR LEAD REPLACEMENT AS SHE WANTED TO SEE HOW THINGS WERE W/O THERAPY. CHEST AND LATERAL X-RAYS WERE PERFORMED BY THE NURSE WHO INDICATED THAT THE PRESENCE OF A LEAD DISCONTINUITY WAS NOT CONFIRMED. NO PATIENT TRAUMA OR MANIPULATION WERE REPORTED TO HAVE CONTRIBUTED TO THE REPORTED HIGH LEAD IMPEDANCE. AT THE MOMENT GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LEAD MODEL 302 | LYJ | CYBERONICS, INC. | 302-20 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 20 YR |