FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL 102
MDR report key: 2082987
·
Received May 4, 2011
Report
- Report Number
- 1644487-2011-00976
- Event Type
- Injury
- Date Received
- May 4, 2011
- Date of Event
- April 4, 2011
- Report Date
- April 11, 2011
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
IT WAS REPORTED BY A VNS PT THAT AFTER SHE ALLERGIC REACTION TO ANTIBIOTICS PRESCRIBED BY NEUROSURGEON, CAPTURED IN MDR# 1644487-2011-00975, SHE WAS TOLD BY HOSPITAL PHYSICIAN THAT SHE HAS AN ABNORMAL EKG. SHE WAS REFERRED TO CARDIOLOGIST BUT THE NAME OF CARDIOLOGIST WAS NOT PROVIDED. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM PT'S NEUROLOGIST HAVE BEEN UNSUCCESSFUL TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 102 | LYJ | CYBERONICS, INC. | 102 | 2561 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Required Intervention |