FDA Adverse Event
Malfunction
Summary report: N
PULSE GEN MODEL 102
MDR report key: 2830199
·
Received November 13, 2012
Report
- Report Number
- 1644487-2012-02982
- Event Type
- Malfunction
- Date Received
- November 13, 2012
- Date of Event
- May 1, 2010
- Report Date
- October 16, 2012
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS INITIALLY REPORTED THAT THE PATIENT HAD A "NON-WORKING" GENERATOR. IT WAS UNCLEAR WHAT WAS MEANT BY NON-WORKING AND IT WAS REPORTED TO HAVE STOPPED WORKING IN 2010 POSSIBLE NEAR THE BEGINNING OF (B)(6). GOOD FAITH ATTEMPTS FOR MORE INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.
Description of Event or Problem · 1
REVIEW OF THE MANUFACTURER'S PROGRAMMING HISTORY DATABASE SHOWED THAT THE PATIENT HAD DIAGNOSTICS WITHIN NORMAL LIMITS ON (B)(6) 2012.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 102 | GENERATOR | LYJ | CYBERONICS, INC. | 102 | 015424 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 6 YR |