FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL 103
MDR report key: 3201158
·
Received July 2, 2013
Report
- Report Number
- 1644487-2013-02008
- Event Type
- Injury
- Date Received
- July 2, 2013
- Date of Event
- June 7, 2013
- Report Date
- June 7, 2013
- Manufacturer
- CYBERONICS INC
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
DEVICE MANUFACTURING RECORDS WERE REVIEWED. REVIEW OF MANUFACTURING RECORDS CONFIRMED STERILIZATION FOR BOTH THE GENERATOR AND LEAD PRIOR TO DISTRIBUTION.
Description of Event or Problem · 1
ON (B)(4) 2013 IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AT THE INCISION SITE AND THAT DRAINS NEED TO BE INSERTED AND POSSIBLE REMOVAL OF THE VNS DEVICE. THE MANUFACTURING RECORDS FOR BOTH THE LEAD AND GENERATOR WERE REVIEWED AND BOTH DEVICES WERE STERILIZED PRIOR TO DISTRIBUTION. ADDITIONAL INFORMATION WAS REQUESTED FROM THE PHYSICIAN¿S OFFICE BUT NO FURTHER INFORMATION HAS BEEN RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 303255 | PULSE GEN MODEL 103 | GENERATOR | LYJ | CYBERONICS INC | 103 | 2734 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 16 YR | Required Intervention |