FDA Adverse Event
Malfunction
Summary report: N
LEAD MODEL UNKNOWN
MDR report key: 1314537
·
Received November 26, 2008
Report
- Report Number
- 1644487-2008-02816
- Event Type
- Malfunction
- Date Received
- November 26, 2008
- Date of Event
- January 1, 2008
- Report Date
- October 27, 2008
- Manufacturer
- CYBERONICS INC
- Product Code
- MUZ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH.
Description of Event or Problem · 1
REPORTER INDICATED THAT THE PATIENT HAD HIGH IMPEDANCE ON A SYSTEM DIAGNOSTICS TEST. THE SURGEON REVIEWED X-RAYS, WHICH DID NOT SHOW A LEAD BREAK. THE DEVICE WAS TURNED OFF AND THE PATIENT HAS BEEN REFERRED FOR REVISION SURGERY. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LEAD MODEL UNKNOWN | MUZ | CYBERONICS INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR |