FDA Adverse Event
Malfunction
Summary report: N
PULSE GEN MODEL 102
MDR report key: 2101946
·
Received May 18, 2011
Report
- Report Number
- 1644487-2011-01091
- Event Type
- Malfunction
- Date Received
- May 18, 2011
- Date of Event
- April 18, 2011
- Report Date
- April 18, 2011
- Manufacturer
- CYBERONICS, INC.
- Product Code
- MUZ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ND, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
A PHYSICIAN REPORTED THAT HE WAS UNABLE TO INTERROGATE A PT'S GENERATOR. INITIALLY, THE PHYSICIAN INDICATED THAT THE PROGRAMMING SYSTEM BEING USED WAS PROPERLY FUNCTIONING. A BATTERY LIFE CALCULATION PERFORMED ON THE PT'S GENERATOR SHOWED THAT IT SHOULD NOT BE AT END-OF-SERVICE. FOLLOW-UP, HOWEVER, REVEALED THAT THE PROGRAMMING SYSTEM'S BATTERY HAD BEEN DEPLETED. THE PT'S GENERATOR, THOUGH, HAS NOT BEEN CONFIRMED AS PROPERLY FUNCTIONING TO DATE. A PT VISIT IN THE NEAR FUTURE IS EXPECTED. GOOD FAITH ATTEMPTS FOR FURTHER INFO HAVE BEEN UNSUCCESSFUL TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 102 | MUZ | CYBERONICS, INC. | 102 | 014188 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR |