FDA Adverse Event
Malfunction
Summary report: N
PULSE GEN MODEL 102
MDR report key: 3002878
·
Received March 13, 2013
Report
- Report Number
- 1644487-2013-00690
- Event Type
- Malfunction
- Date Received
- March 13, 2013
- Date of Event
- February 1, 2013
- Report Date
- February 13, 2013
- Manufacturer
- CYBERONICS INC
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT'S MOTHER BELIEVES THAT THERE IS AN "ISSUE" WITH THE PATIENT'S DEVICE AND THAT THE BATTERY MAY BE DEAD. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 105916 | PULSE GEN MODEL 102 | GENERATOR | LYJ | CYBERONICS INC | 102 | 2329 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 23 YR |