FDA Adverse Event
Death
Summary report: N
PULSE GEN MODEL 102R
MDR report key: 3910249
·
Received July 2, 2014
Report
- Report Number
- 1644487-2014-01669
- Event Type
- Death
- Date Received
- July 2, 2014
- Date of Event
- April 25, 2008
- Report Date
- June 4, 2014
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
TYPE OF REPORTABLE EVENT, CORRECTED DATA: THE ¿DEATH¿ FIELD WAS INADVERTENTLY NOT MARKED ON FOLLOW-UP REPORT#1.
Additional Manufacturer Narrative · 1
TYPE OF REPORTABLE EVENT, CORRECTED DATA: THE TYPE OF REPORTABLE EVENT WAS INADVERTENTLY MARKED AS MALFUNCTION IN THE INITIAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE VNS PATIENT PASSED AWAY. THE FUNERAL HOME REPORTED THAT THE PATIENT PASSED AWAY FROM RESPIRATORY ARREST DUE TO UPPER RESPIRATORY PNEUMONIA AS WELL AS EPILEPSY AND SEVERE DEVELOPMENTAL DELAY. THE PHYSICIAN'S NURSE REPORTED THAT THE PATIENT WAS VERY SICK AND SHE DOESN'T BELIEVE IT HAD ANYTHING TO DO WITH HER VNS DEVICE. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 386730 | PULSE GEN MODEL 102R | GENERATOR | LYJ | CYBERONICS, INC. | 102R | 012303 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 9 YR | Death |