FDA Adverse Event
Malfunction
Summary report: N
BIPOL LEAD MODEL 300
MDR report key: 1191909
·
Received October 1, 2008
Report
- Report Number
- 1644487-2008-02380
- Event Type
- Malfunction
- Date Received
- October 1, 2008
- Date of Event
- September 4, 2008
- Report Date
- September 4, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE FAILURE IS SUSPECTED, BUD DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.
Description of Event or Problem · 1
REPORTER INDICATED THAT THE PT WAS TO UNDERGO SURGERY FOR PROPHYLACTIC BATTERY REPLACEMENT. HOWEVER, AT THE TIME OF SURGERY, IT WAS DISCOVERED THERE WAS HIGH LEAD IMPEDANCE. AT THAT TIME, IT WAS DECIDED THAT THE ENTIRE DEVICE WOULD BE REMOVED AND NOT REPLACED. ALL ATTEMPTS FOR FURTHER INFO ARE PENDING. PRODUCTS HAVE BEEN RETURNED TO MFR, BUT ANALYSIS IS PENDING.
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 | 14 YR |