FDA Adverse Event
Malfunction
Summary report: N
BIPOL LEAD MODEL 300
MDR report key: 1963682
·
Received December 21, 2010
Report
- Report Number
- 1644487-2010-02866
- Event Type
- Malfunction
- Date Received
- December 21, 2010
- Date of Event
- February 15, 2005
- Report Date
- November 24, 2010
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 1
REVIEW OF PROGRAMMING/DEVICE DIAGNOSTIC HISTORY.
Description of Event or Problem · 1
IT WAS INITIALLY REPORTED BY THE PHYSICIAN THAT THE PT'S GENERATOR WAS UNABLE TO BE INTERROGATED AT A RECENT APPT AND BELIEVED TO BE AT END OF SERVICE. DURING REVIEW OF THE MFR'S PROGRAMMING HISTORY DATABASE IT SHOWED HIGH IMPEDANCE ON ALL DIAGNOSTICS. PT HAS BEEN REFERRED TO A SURGEON FOR A FULL REVISION. (B)(4) 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 | 3979 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR | Male | Other |