FDA Adverse Event
Malfunction
Summary report: N
LEAD MODEL UNKNOWN
MDR report key: 3201139
·
Received July 2, 2013
Report
- Report Number
- 1644487-2013-02007
- Event Type
- Malfunction
- Date Received
- July 2, 2013
- Date of Event
- June 5, 2013
- Report Date
- June 5, 2013
- Manufacturer
- CYBERONICS INC
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- 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, IT WAS REPORTED THAT A SYSTEM DIAGNOSTIC RETURNED DCDC=7 INDICATING HIGH IMPEDANCE. THE GENERATOR WAS NORMAL, AND X-RAYS WERE TO BE TAKEN; HOWEVER, ATTEMPTS FOR ANY ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL. IT WAS STATED THAT THE GENERATOR WAS NEVER PROGRAMMED ON AFTER GENERATOR REVISION IN 2012.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 301610 | LEAD MODEL UNKNOWN | LEAD | LYJ | CYBERONICS INC | NI | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |