BEUDAMED
    FDA Adverse Event Death Summary report: N

    KAINOX SL 75/16

    MDR report key: 1326815 · Received February 24, 2009

    Report

    Report Number
    1028232-2009-00324
    Event Type
    Death
    Date Received
    February 24, 2009
    Date of Event
    February 9, 2008
    Report Date
    February 9, 2009
    Manufacturer
    BIOTRONIK GMBH AND CO.
    Product Code
    LWS
    PMA / PMN Number
    P980023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THIS LEAD WAS RETURNED WITHOUT OOS DOCUMENTATION FROM MEDTRONIC, INC. PER MEDTRONIC, THIS PATIENT EXPIRED. PER THE PHYSICIAN'S OFFICE, THIS PATIENT WAS BROUGHT TO THE ER IN CARDIAC ARREST IN 2008, THE DATE OF DEATH AND EXPLANT ARE UNKNOWN. THERE ARE NO COMPLAINTS ASSOCIATED WITH THIS LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KAINOX SL 75/16 ICD LEAD LWS BIOTRONIK GMBH AND CO. 124218

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death