FDA Adverse Event
Malfunction
Summary report: N
LEAD MODEL 302
MDR report key: 3192677
·
Received June 27, 2013
Report
- Report Number
- 1644487-2013-01945
- Event Type
- Malfunction
- Date Received
- June 27, 2013
- Date of Event
- June 30, 2012
- Report Date
- June 4, 2013
- Manufacturer
- CYBERONICS INC
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- 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
ON (B)(6) 2013 DURING REVIEW OF THE PATIENT¿S PROGRAMMING HISTORY IT WAS OBSERVED THAT HIGH IMPEDANCE HAD BEEN SEEN ON (B)(6) 2012. THE IMPEDANCE APPEARED TO HAVE BEEN FINE IN (B)(6) 2012 AND THEN LATER IN (B)(6) 2012. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 294222 | LEAD MODEL 302 | LEAD | LYJ | CYBERONICS INC | 302-20 | 1239 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 14 YR |