FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL UNK
MDR report key: 1120741
·
Received August 15, 2008
Report
- Report Number
- 1644487-2008-01921
- Event Type
- Injury
- Date Received
- August 15, 2008
- Date of Event
- January 1, 2004
- Report Date
- July 16, 2008
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
"COMPLETE HEART BLOCK WITH VENTRICULAR ASYSTOLE DURING LEFT VAGUS NERVE STIMULATION FOR EPILEPSY." EPILEPSY & BEHAVIOR 5 (2004) 768-771. SEE SCANNED PAGES.
Description of Event or Problem · 1
IT WAS REPORTED IN AN ARTICLE THAT DURING INITIAL VNS PLACEMENT, AN INTRAOPERATIVE SYSTEM DIAGNOSTIC TEST RESULTED IN A 9-S PERIOD OF VENTRICULAR ASYSTOLE WITH HYPOTENSION. A PRE-OPERATIVE ECG HAD SHOWN FIRST-DEGREE HEART BLOCK. SUBSEQUENT CARDIAC EVAL WAS UNREMARKABLE. THE DEVICE WAS LEFT IN PLACE, AND SUBSEQUENT ACTIVATION OF THE VNS DEVICE DID NOT RESULT IN ANY SIGNIFICANT PROBLEMS. REVIEW OF THE PT'S MEDICAL RECORDS DID NOT REVEAL ANY EVIDENCE OF PREVIOUS CARDIAC DISEASE. GOOD FAITH ATTEMPTS TO OBTAIN ADD'L INFO HAVE BEEN UNSUCCESSFUL TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL UNK | LYJ | CYBERONICS, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR | Other |