FDA Adverse Event
Malfunction
Summary report: N
LEAD MODEL 302
MDR report key: 2061983
·
Received April 6, 2011
Report
- Report Number
- 1644487-2011-00726
- Event Type
- Malfunction
- Date Received
- April 6, 2011
- Date of Event
- March 1, 2011
- Report Date
- March 14, 2011
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.
Description of Event or Problem · 1
ON (B)(4) 2011, IT WAS REPORTED BY THE VNS PT'S SURGEON THAT THE VNS PT WILL BE HAVING A FULL REVISION SURGERY ON (B)(6) 2011 DUE TO A LEAD FRACTURE, X-RAYS WERE TAKEN AND THE SURGEON CONFIRMED THAT A FRACTURE OF THE LEAD WAS NOTICEABLE. THE SURGEON WAS UNSURE OF THE CAUSE OF THE LEAD FRACTURE. THE SURGERY TOOK PLACE ON (B)(6) 2011 AND THE EXPLANTED PRODUCT WAS RETURNED TO THE MANUFACTURER FOR PRODUCT ANALYSIS. PRODUCT ANALYSIS IS PENDING COMPLETION. GOOD FAITH ATTEMPTS TO THE SURGEON FOR MORE INFO HAVE BEEN UNSUCCESSFUL TO DATE. WHEN MORE INFO IS RECEIVED, IT WILL BE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LEAD MODEL 302 | LYJ | CYBERONICS, INC. | 302-20 | 200417 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 19 YR |