FDA Adverse Event
Malfunction
Summary report: N
BIPOL LEAD MODEL 302
MDR report key: 868340
·
Received June 21, 2007
Report
- Report Number
- 1644487-2007-00872
- Event Type
- Malfunction
- Date Received
- June 21, 2007
- Date of Event
- May 1, 2007
- Report Date
- May 22, 2007
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
MFR ASSESSED PT X-RAYS. MFR REVIEW OF X-RAYS YIELDED NO ANOMALIES. DEVICE MALFUNCTION IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY
Description of Event or Problem · 1
REPORTER INDICATED THAT PT PRESENTED FOR ROUTINE OFFICE VISIT WHERE HIGH LEAD IMPEDANCE WAS OBTAINED ON A SYSTEM DIAGNOSTICS TEST, AND ON A NORMAL MODE DIAGNOSTICS TEST, INDICATING A POSSIBLE LEAD MALFUNCTION. PT X-RAYS WERE SENT TO MFR FOR REVIEW. ASSESSMENT OF X-RAYS YIELDED NO ANOMALIES. GOOD FAITH ATTEMPTS TO OBTAIN FURTHER INFO ARE CURRENTLY BEING MADE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIPOL LEAD MODEL 302 | LYJ | CYBERONICS, INC. | 302-20 | 1090 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR |