FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL 103
MDR report key: 3053412
·
Received April 11, 2013
Report
- Report Number
- 1644487-2013-00994
- Event Type
- Injury
- Date Received
- April 11, 2013
- Date of Event
- April 4, 2013
- Report Date
- April 4, 2013
- Manufacturer
- CYBERONICS INC
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DEVICE MANUFACTURING RECORDS WERE REVIEWED. REVIEW OF MANUFACTURING RECORDS CONFIRMED STERILIZATION FOR BOTH THE LEAD AND GENERATOR PRIOR TO DISTRIBUTION.
Description of Event or Problem · 1
ON (B)(6) 2013, IT WAS REPORTED THAT THE VNS PATIENT HAD AN INFECTION POST IMPLANT THAT WAS THOUGHT TO BE CAUSED BY AN UNDIAGNOSED URINARY TRACT INFECTION. NO FURTHER INFORMATION WAS PROVIDED. REVIEW OF MANUFACTURING RECORDS CONFIRMED STERILIZATION FOR BOTH THE GENERATOR AND LEAD PRIOR TO DISTRIBUTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 156723 | PULSE GEN MODEL 103 | GENERATOR | LYJ | CYBERONICS INC | 103 | 202176 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |