FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL 103
MDR report key: 2892455
·
Received January 2, 2013
Report
- Report Number
- 1644487-2013-00004
- Event Type
- Injury
- Date Received
- January 2, 2013
- Date of Event
- November 28, 2012
- Report Date
- December 4, 2012
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
ON (B)(6) 2012, CLINIC NOTES FROM A VNS TREATING PHYSICIAN WERE RECEIVED. REVIEW OF THE CLINIC NOTES DATED (B)(6), 2012 REVEALED THAT THE PATIENT HAS SYNCOPE. GOOD FAITH ATTEMPTS FOR FURTHER INFORMATION FROM THE PHYSICIAN WERE MADE BUT WERE UNSUCCESSFUL.
Description of Event or Problem · 1
ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2013 WHEN THE PATIENT'S IMPLANTED LEAD INFORMATION WAS PROVIDED BY THE IMPLANTING HOSPITAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1843 | PULSE GEN MODEL 103 | GENERATOR | LYJ | CYBERONICS, INC. | 103 | 2160 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 14 YR | Other |