BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 2210289 · Received August 10, 2011

    Report

    Report Number
    1644487-2011-01833
    Event Type
    Death
    Date Received
    August 10, 2011
    Date of Event
    December 22, 2009
    Report Date
    July 13, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    MFR RECEIVED EXPLANTED GENERATOR AND LEAD ON (B)(6) 2011 FROM MEDTRONICS COMPANY WHICH HAD RECEIVED THE PRODUCTS INCORRECTLY. MFR IDENTIFIED THAT GENERATOR AND LEAD BELONGED TO A VNS PT WHO PASSED AWAY ON (B)(6) 2009. GOOD FAITH ATTEMPTS TO OBTAIN MORE INFO REGARDING PT'S DEATH HAVE BEEN UNSUCCESSFUL TO DATE. MFR COMPLETED THE ANALYSIS ON THE LEAD AND THE CONDITION OF THE RETURNED LEAD PORTION IS CONSISTENT WITH EXPLANT PROCEDURE CONDITION. THE RESISTANCE MEASUREMENT TAKEN DURING DECONTAMINATION VERIFIED AN ELECTRICAL AND MECHANICAL CONTACT BETWEEN THE GENERATOR AND CONNECTOR PIN AT ONE POINT IN TIME. CONTINUITY CHECKS OF THE RETURNED LEAD PORTION WERE PERFORMED, DURING THE VISUAL ANALYSIS, WITH NO DISCONTINUITIES IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 103 LYJ CYBERONICS, INC. 103 2151

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Death