FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL 102R
MDR report key: 4063628
·
Received September 5, 2014
Report
- Report Number
- 1644487-2014-02250
- Event Type
- Injury
- Date Received
- September 5, 2014
- Date of Event
- January 21, 2010
- Report Date
- August 8, 2014
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE PREVIOUSLY SUBMITTED MANUFACTURER REPORT INADVERTENTLY INCLUDED THE INCORRECT DATE OF EVENT. THIS REPORT IS BEING SUBMITTED TO CORRECT THIS DATA. THE PREVIOUSLY SUBMITTED MANUFACTURER REPORT INADVERTENTLY INCLUDED THE INCORRECT DATE OF EXPLANT. THIS REPORT IS BEING SUBMITTED TO CORRECT THIS DATA.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT UNDERWENT VNS EXPLANT DUE TO INFECTION. IT WAS REPORTED THAT THE PATIENT HAD RECENTLY UNDERGONE GENERATOR REPLACEMENT. IT WAS REPORTED THAT THE PATIENT WAS NEVER REIMPLANTED. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 545351 | PULSE GEN MODEL 102R | GENERATOR | LYJ | CYBERONICS, INC. | 102R | 201204 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 28 YR | Required Intervention |