FDA Adverse Event
Malfunction
Summary report: N
BIPOL LEAD MODEL 300
MDR report key: 2040864
·
Received March 21, 2011
Report
- Report Number
- 1644487-2011-00593
- Event Type
- Malfunction
- Date Received
- March 21, 2011
- Date of Event
- February 19, 2011
- Report Date
- February 19, 2011
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
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
A COMPANY REP WAS REQUESTED TO BE PRESENT AT A PT'S APPOINTMENT IN ORDER TO EVALUATE THE LEAD'S IMPEDANCE. AT THE APPOINTMENT ON (B)(6) 2011, IT WAS FOUND THAT THE PT HAD HIGH LEAD IMPEDANCE AND A LOW OUTPUT CURRENT. THE PT WAS THEN SCHEDULED FOR A FULL REVISION, AND AN X-RAY WAS REPORTED TO HAVE BEEN PERFORMED. HOWEVER, THE PHYSICIAN DID NOT WISH TO SEND THEM TO THE MFR FOR REVIEW. FURTHER INFO REC'D FROM THE PHYSICIAN INDICATED THAT THE PT WAS NOT EXPERIENCING ANY PAIN AND HAD NO DISCOMFORT. ATTEMPTS TO GAIN MORE INFO HAVE BEEN UNSUCCESSFUL TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIPOL LEAD MODEL 300 | LYJ | CYBERONICS, INC. | 300-20 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR |