FDA Adverse Event
Malfunction
Summary report: N
LEAD MODEL 302
MDR report key: 1963426
·
Received December 20, 2010
Report
- Report Number
- 1644487-2010-02849
- Event Type
- Malfunction
- Date Received
- December 20, 2010
- Date of Event
- November 12, 2010
- Report Date
- November 23, 2010
- Manufacturer
- CYBERONICS INC
- Product Code
- MUZ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
- Health Professional
- Yes
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
IT WAS REPORTED BY VNS PT'S SPOUSE THAT THE PSYCHIATRIST NOTED HIGH IMPEDANCE DURING OFFICE VISIT. ADDITIONALLY, THE PHYSICIAN WAS NOT ABLE TO ADJUST THE SETTINGS AND STATED THAT THE DEVICE WAS "NOT OPERATING PROPERLY". F/U WITH THE PHYSICIAN REVEALED PT HAD HIGH IMPEDANCE. THE PHYSICIAN WAS INFORMED BY A COMPANY REP THAT THIS MAY BE RELATED TO LEAD BREAKAGE, FIBROSIS, OR PIN INSERTION ISSUE AND WAS SUGGESTED TO TURN OFF THE GENERATOR AND ORDER X-RAYS FOR THE PT. (B)(4) ATTEMPTS TO OBTAIN INFO ABOUT PT MANIPULATION AND TRAUMA WERE UNSUCCESSFUL TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LEAD MODEL 302 | MUZ | CYBERONICS INC | 302-20 | 200256 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Female |