FDA Adverse Event
Malfunction
Summary report: N
PULSE GEN MODEL 103
MDR report key: 4103264
·
Received September 19, 2014
Report
- Report Number
- 1644487-2014-02412
- Event Type
- Malfunction
- Date Received
- September 19, 2014
- Date of Event
- August 22, 2014
- Report Date
- August 22, 2014
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING INITIAL IMPLANT SURGERY, THE SURGEON WAS UNABLE TO GET THE SETSCREW TO TORQUE INITIALLY USING THE TORQUE WRENCH. ANOTHER ACCESSORY PACK WAS OPENED AND A NEW TORQUE WRENCH WAS USED AND WAS ABLE TO GET THE SETSCREW TO CLICK AS INTENDED. DEVICE DIAGNOSTICS AFTER THE SETSCREW WAS IN PLACE WAS WITHIN NORMAL LIMITS (1805 OHMS).
Description of Event or Problem · 1
ADDITIONAL INFORMATION WAS RECEIVED THAT THE TORQUE WRENCH USED IN THE PATIENT'S SURGERY WAS DISCARDED AND IS UNABLE TO BE RETURNED FOR PRODUCT ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 582320 | PULSE GEN MODEL 103 | GENERATOR | LYJ | CYBERONICS, INC. | 103 | 202699 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 36 YR |