FDA Adverse Event
Malfunction
Summary report: N
PULSE GEN MODEL 103
MDR report key: 1190795
·
Received September 24, 2008
Report
- Report Number
- 1644487-2008-02313
- Event Type
- Malfunction
- Date Received
- September 24, 2008
- Date of Event
- August 14, 2008
- Report Date
- August 14, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE MALFUNCTION IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.
Description of Event or Problem · 1
REPORTER INDICATED A VNS GENERATOR PRODUCED AN ERROR MESSAGE "LOW LEAD IMPEDANCE LESS THAN OR EQUAL TO 200 OHMS. LEAD IMPEDANCE HAS BEEN DETECTED" DURING AN INITIAL IMPLANT SURGERY. TROUBLESHOOTING DID NOT RESOLVE THE ISSUE. A DIFFERENT GENERATOR WAS IMPLANTED WITHOUT COMPLICATION. THE GENERATOR WAS RETURNED TO THE MANUFACTURER AND IS PENDING PRODUCT ANALYSIS. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFO HAVE BEEN UNSUCCESSFUL TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 103 | LYJ | CYBERONICS, INC. | 103 | 200778 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 16 YR |