FDA Adverse Event
Malfunction
Summary report: N
BIPOL LEAD MODEL 300
MDR report key: 3172602
·
Received June 17, 2013
Report
- Report Number
- 1644487-2013-01795
- Event Type
- Malfunction
- Date Received
- June 17, 2013
- Date of Event
- January 1, 2003
- Report Date
- May 21, 2013
- Manufacturer
- CYBERONICS INC
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SW
- Reporter Occupation
- PHYSICIAN
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
DURING REVIEW OF THE PATIENT¿S PROGRAMMING HISTORY ON (B)(6) 2013 IT WAS FOUND THAT HIGH IMPEDANCE HAD BEEN OBSERVED. INFORMATION AVAILABLE TO DATE INDICATES THAT THE HIGH LEAD IMPEDANCE DATE CANNOT BE VERIFIED DUE TO INCORRECT DIAGNOSTIC DATES ASSOCIATED WITH VARIOUS INTERROGATIONS/PROGRAMMING EVENTS RECORDED IN THE PROGRAMMING HISTORY. FURTHER INFORMATION HAS BEEN REQUESTED FROM THE PHYSICIAN BUT NO ADDITIONAL INFORMATION HAS BEEN RECEIVED TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 273299 | BIPOL LEAD MODEL 300 | LEAD | LYJ | CYBERONICS INC | 300-20 | 5213 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |