FDA Adverse Event
Injury
Summary report: N
LEAD MODEL 304
MDR report key: 2833648
·
Received November 15, 2012
Report
- Report Number
- 1644487-2012-03013
- Event Type
- Injury
- Date Received
- November 15, 2012
- Date of Event
- July 31, 2012
- Report Date
- October 23, 2012
- Manufacturer
- CYBERONICS INC
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DEVICE MANUFACTURING RECORDS WERE REVIEWEDREVIEW OF MANUFACTURING RECORDS CONFIRMED STERILIZATION FOR BOTH THE GENERATOR AND LEAD PRIOR TO DISTRIBUTION.
Description of Event or Problem · 1
ON (B)(6) 2012, IT WAS REPORTED THAT THE VNS PATIENT HAD AN INFECTION OF HIS LEAD AND GENERATOR AFTER THE MOST RECENT SYSTEM REVISION ON (B)(6) 2012. THE EXACT START DATE OF THE INFECTION/EXTRUSION WAS UNKNOWN AND THE PHYSICIAN INDICATED THAT THE PATIENT PICKED AT THE LEAD INCISION SITE, WHICH CAUSED IT TO EXTRUDE AND THEN BECOME INFECTED. THE PATIENT HAD HIS LEAD AND GENERATOR EXPLANTED ON (B)(6) 2012 DUE TO THE INFECTION AND WAS RE-IMPLANTED LATER ON (B)(6) 2012. 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 |
|---|---|---|---|---|---|---|---|
| 1 | LEAD MODEL 304 | LEAD | LYJ | CYBERONICS INC | 304-20 | 3322 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 10 YR | Required Intervention |