FDA Adverse Event
Malfunction
Summary report: N
PULSE GEN MODEL 102
MDR report key: 1963860
·
Received December 22, 2010
Report
- Report Number
- 1644487-2010-02881
- Event Type
- Malfunction
- Date Received
- December 22, 2010
- Date of Event
- April 1, 2010
- Report Date
- November 22, 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
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PHYSICIAN COULD NOT INTERROGATE THE PATIENT'S VNS AT A ROUTINE OFFICE VISIT. THE PATIENT HAD OPEN HEART SURGERY IN APRIL AND SINCE THEN SHE HAS HAD SWELLING IN HER LEFT BREAST. THE PHYSICIAN WAS ABLE TO INTERROGATE AND PROGRAM THE PATIENT'S VNS ON FOLLOWING THE OPEN HEART SURGERY. NO PROGRAMMING HISTORY IS AVAILABLE TO ESTIMATE THE REMAINING VNS BATTERY LIFE. THE PHYSICIAN REPORTED THAT HE HAD BEEN ABLE TO INTERROGATE OTHER PATIENT'S VNS GENERATORS.
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 | 48 YR |