FDA Adverse Event
Malfunction
Summary report: N
VNS THERAPY PULSE
MDR report key: 555051
·
Received April 30, 2004
Report
- Report Number
- 1644487-2004-00403
- Event Type
- Malfunction
- Date Received
- April 30, 2004
- Report Date
- April 2, 2004
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
DEVICE INTERROGATION REVEALED THAT THE PT'S GENERATOR WAS PROGRAMMED TO OMA OUTPUT CURRENT INSTEAD OF TO THE PRESCRIBED PARAMETERS. IT IS SUSPECTED THAT USER ERROR DURING PREVIOUS PROGRAMMING SESSION CAUSED THE DEVICE TO BE INADVERTENTLY PROGRAMMED TO OMA OUTPUT CURRENT. NO ADVERSE EVENT WAS REPORTED IN CONJUNCTION WITH THE SUSPECTED PROGRAMMING ANOMALY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VNS THERAPY PULSE | PULSE GENERATOR | LYJ | CYBERONICS, INC. | 102 | 7342 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 32 YR | DATE OF MFG 10/30/2002, STERILIZATION LOT NO.| 7272.| MODEL 302-20 VNS THERAPY LEAD, |