FDA Adverse Event
Malfunction
Summary report: N
LEAD MODEL UNKNOWN
MDR report key: 2152448
·
Received June 22, 2011
Report
- Report Number
- 1644487-2011-01404
- Event Type
- Malfunction
- Date Received
- June 22, 2011
- Date of Event
- May 18, 2011
- Report Date
- May 23, 2011
- Manufacturer
- CYBERONICS, INC.
- Product Code
- MUZ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 1
DEVICE MALFUNCTION SUSPECTED BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.
Description of Event or Problem · 1
IT WAS REPORTED TO OUR COUNTRY REP IN THE (B)(6). THAT THERE WAS A VNS PT WITH HIGH LEAD IMPEDANCE ON THEIR SYSTEM DIAGNOSTIC TESTING. THE LAST TIME THEIR RESULTS WERE WITHIN NORMAL LIMITS WAS ON (B)(6) 2009. NO PT HISTORY OF TRAUMA PRECEDING THE EVENT. THE DEVICE WAS PROGRAMMED OFF. THE SITE PHYSICIAN REVIEWED X-RAYS AND NO OBVIOUS LEAD BREAK NOTED. THE PT IS BEING REFERRED TO THEIR SURGEON FOR REVIEW.
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 | 18 YR | Male |