FDA Adverse Event
Malfunction
Summary report: N
PULSE GEN MODEL 102
MDR report key: 1203388
·
Received October 15, 2008
Report
- Report Number
- 1644487-2008-02509
- Event Type
- Malfunction
- Date Received
- October 15, 2008
- Date of Event
- September 17, 2008
- Report Date
- September 17, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- MUZ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
REPORTER INDICATED TO A MANUFACTURING CONSULTANT, THAT ONE OF THEIR VNS PATIENT'S WAS UNABLE TO HAVE THEIR GENERATOR INTERROGATED. PROGRAMMING SYSTEMS WERE CHECKED AND RULED OUT AS THE CAUSE OF THE COMMUNICATION ISSUE. THE PATIENT DOES NOT FEEL STIMULATION AND THEY DO NOT HAVE A VOICE CHANGE AT PROGRAMMED INTERVALS. REVISION SURGERY WILL BE PLANNED. GOOD FAITH ATTEMPTS WILL BE MADE FOR THE EXPLANTED PRODUCT FOR ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 102 | MUZ | CYBERONICS, INC. | 102 | 013620 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR |