FDA Adverse Event
Malfunction
Summary report: N
PULSE GEN MODEL 101
MDR report key: 3221281
·
Received July 11, 2013
Report
- Report Number
- 1644487-2013-02076
- Event Type
- Malfunction
- Date Received
- July 11, 2013
- Date of Event
- September 3, 2008
- Report Date
- June 18, 2013
- Manufacturer
- CYBERONICS INC
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
ON (B)(6) 2013 A VNS TREATING PHYSICIAN REPORTED THAT ON (B)(6) 2008 A NURSE PRACTITIONER INTERROGATED THE PATIENT¿S VNS AND DISCOVERED THAT THE DEVICE AND MAGNET WERE DISABLED. SHE HAD NOT SEEN THE PATIENT FOR 15 MONTHS PRIOR TO THIS VISIT SO IT WAS NOT KNOWN HOW OR WHEN THIS HAPPENED. THE PATIENT ALSO DID NOT KNOW THAT THE DEVICE HAD NOT BEEN ON. THE PHYSICIAN STATED THAT THE PATIENT¿S DEVICE HAD NOT BEEN DISABLED INTENTIONALLY BY ANYONE IN THEIR OFFICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 319909 | PULSE GEN MODEL 101 | GENERATOR | LYJ | CYBERONICS INC | 101 | 4344 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR |