FDA Adverse Event
Malfunction
Summary report: N
BIPOL LEAD MODEL 300
MDR report key: 960126
·
Received December 7, 2007
Report
- Report Number
- 1644487-2007-02108
- Event Type
- Malfunction
- Date Received
- December 7, 2007
- Date of Event
- October 25, 2007
- Report Date
- November 7, 2007
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DEVICE MALFUNCTION IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.
Description of Event or Problem · 1
RPTR INDICATED THE PT PRESENTED TO THE PHYSICIAN'S OFFICE WITH HIGH LEAD IMPEDANCE, INDICATING A POSSIBLE LEAD MALFUNCTION. THE PHYSICIAN ALSO INDICATED THE PT HAD HIGH LEAD IMPEDANCE DURING THE PT'S GENERATOR REPLACEMENT SURGERY. THE PHYSICIAN HAS ORDERED X-RAYS AND THE PT'S GENERATOR WAS TURNED OFF TO 0MA. GOOD FAITH ATTEMPTS TO OBTAIN ADD'L INFO ARE BEING MADE, BUT 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 | 23535C |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR |