FDA Adverse Event
Malfunction
Summary report: N
PULSE GEN MODEL 103
MDR report key: 2780010
·
Received October 10, 2012
Report
- Report Number
- 1644487-2012-02571
- Event Type
- Malfunction
- Date Received
- October 10, 2012
- Date of Event
- September 12, 2010
- Report Date
- September 12, 2012
- Manufacturer
- CYBERONICS INC
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER CAREGIVERS
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
REPORTER INDICATED A VNS PATIENT WAS EXPERIENCING RECENT INCREASED DEPRESSION AND AGGRESSION. THE EVENTS STARTED "YEARS AGO" BUT ONLY RECENTLY WORSENED.ATTEMPTS FOR FURTHER INFORMATION FROM THE TREATING PHYSICIAN ARE IN PROGRESS.
Description of Event or Problem · 1
REPORTER INDICATED THE PATIENT'S INCREASED DEPRESSION AND AGGRESSION ARE NOT RELATED TO THE VNS, AND WERE WORSENING PRIOR TO THE IMPLANTATION OF THE VNS. CURRENT VNS DIAGNOSTICS WERE REPORTED AS "NORMAL", BUT EXACT VALUES WERE NOT PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 103 | PULSE GEN MODEL 103 | LYJ | CYBERONICS INC | 103 | 2565 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 14 YR |