BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL UNK

    MDR report key: 2153052 · Received June 28, 2011

    Report

    Report Number
    1644487-2011-01442
    Event Type
    Death
    Date Received
    June 28, 2011
    Report Date
    June 6, 2011
    Manufacturer
    CYBERONICS INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY A NURSE THAT A PT WHO WAS IMPLANTED WITH VNS DEVICE HAD PASSED AWAY. THE NURSE HOWEVER, DID NOT KNOW THE DETAILS OF PT'S DEATH OR ITS RELATIONSHIP TO VNS. THE MANUFACTURER DOES NOT HAVE A RECORD OF PT BEING IMPLANTED AFTER (B)(6) 2003 WHERE PT'S GENERATOR WAS EXPLANTED DUE TO INFECTION (REPORTED IN MDR # 1644487-2003-00079). THE TREATING PHYSICIAN NO LONGER PRACTICES AND MANUFACTURER HASN'T BEEN ABLE TO CONFIRM PT'S DEATH OR VNS IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL UNK LYJ CYBERONICS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Death