FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL 102
MDR report key: 1983037
·
Received February 7, 2011
Report
- Report Number
- 1644487-2011-00201
- Event Type
- Injury
- Date Received
- February 7, 2011
- Date of Event
- December 20, 2010
- Report Date
- January 11, 2011
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DEVICE MANUFACTURING RECORDS WERE REVIEWED. REVIEW OF MANUFACTURING RECORDS CONFIRMED STERILIZATION PRIOR TO DISTRIBUTION.
Description of Event or Problem · 1
A VNS PHYSICIAN IN (B)(6) REPORTED THAT THEY HAD A PATIENT WHO WAS IMPLANTED ON (B)(6) 2010, PRESENTED WITH AN INFECTION ABOUT 3 WEEKS AFTER THE IMPLANT. ANTIBIOTIC TREATMENT WAS GIVEN FOR 2 WEEKS, AND THE INFECTION WAS WASHED, BUT ULTIMATELY THE GENERATOR WAS EXPLANTED ((B)(6) 2010) AND THE LEAD EXPLANTED ((B)(6)2011). THE EXPLANTED PRODUCTS WERE DISCARDED. THE PATIENT IS DOING WELL SINCE EXPLANT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 102 | LYJ | CYBERONICS, INC. | 102 | 201181 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 10 YR | Hospitalization| R |