FDA Adverse Event
Injury
Summary report: N
PULSE GEN MODEL 103
MDR report key: 1905623
·
Received November 19, 2010
Report
- Report Number
- 1644487-2010-02614
- Event Type
- Injury
- Date Received
- November 19, 2010
- Date of Event
- September 21, 2010
- Report Date
- October 22, 2010
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BE
- Reporter Occupation
- OTHER
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
A VNS SURGEON'S OFFICE REPORTED TO OUR COUNTRY REPRESENTATIVE IN (B)(6) THAT THEY HAD A VNS PT WHO DEVELOPED A POSTOPERATIVE INFECTION AT THE GENERATOR INCISION SITE WITH WOUND DEHISCENCE AND HAD THEIR VNS GENERATOR EXPLANTED. THE PT'S INFECTION IS BEING ATTRIBUTED TO THEIR IMPLANTATION OF THE VNS. NO PT TRAUMA OR MANIPULATION OF THEIR VNS SITE WAS REPORTED PRIOR TO THEIR INFECTION. THEIR INFECTION HAS SINCE RESOLVED AND THE PT WILL BE GETTING ANOTHER IMPLANTATION OF THE VNS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE GEN MODEL 103 | LYJ | CYBERONICS, INC. | 103 | 2542 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 18 YR | Hospitalization| R |