FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL 102
MDR report key: 1924674
·
Received December 7, 2010
Report
- Report Number
- 1644487-2010-02745
- Event Type
- Injury
- Date Received
- December 7, 2010
- Date of Event
- September 23, 2008
- Report Date
- November 19, 2010
- Manufacturer
- CYBERONICS, INC.
- Product Code
- MUZ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT A VNS PATIENT'S DEVICE HAD MIGRATED UNDER HER ARMPIT DUE TO UNKNOWN REASON. NO FALL OR INJURY PRECEDING MIGRATION EVENT WAS REPORTED. FURTHER INFORMATION WAS RECEIVED FROM A COMPANY REPRESENTATIVE INDICATING THE PATIENT WAS RECENTLY RE-EVALUATED BY HER TREATING PHYSICIAN. PATIENT WAS CONCERNED WITH HER DEVICE MIGRATING AS THE PATIENT HAD BEEN CLEANING HER FRIDGE VIGOROUSLY AND THE SUTURE MAY HAVE RIPPED AT THIS POINT. PATIENT AT THIS TIME WANTS TO AT LEAST HAVE HER GENERATOR RE-SUTURED DOWN IN THE POCKET SITE. HOWEVER, AT THE TIME NO ADDITIONAL INFORMATION HAS BEEN RECEIVED INDICATING A SCHEDULE DATE FOR THE INTERVENTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 102 | MUZ | CYBERONICS, INC. | 102 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Required Intervention |