FDA Adverse Event
Malfunction
Summary report: N
PULSE GEN MODEL 102
MDR report key: 4130268
·
Received September 30, 2014
Report
- Report Number
- 1644487-2014-02519
- Event Type
- Malfunction
- Date Received
- September 30, 2014
- Date of Event
- August 8, 2014
- Report Date
- September 5, 2014
- Manufacturer
- CYBERONICS INC
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
DEVICE MANUFACTURING RECORDS WERE REVIEWED. REVIEW OF MANUFACTURING RECORDS CONFIRMED THAT THE GENERATOR PASSED ALL FUNCTIONAL TESTS PRIOR TO DISTRIBUTION.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE VNS PATIENT¿S DEVICE COULD NOT BE INTERROGATED DURING AN OFFICE VISIT ON (B)(6) 2014. IT IS UNKNOWN IF THE PATIENT¿S DEVICE WAS AT END OF SERVICE. NO KNOWN SURGICAL INTERVENTIONS HAVE OCCURRED TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 607740 | PULSE GEN MODEL 102 | GENERATOR | LYJ | CYBERONICS INC | 102 | 016943 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 18 YR |