BEUDAMED
    FDA Adverse Event Death Summary report: N

    1310P MEDITRACE 2/PK 20/CA

    MDR report key: 654510 · Received December 21, 2005

    Report

    Report Number
    9681860-2005-00010
    Event Type
    Death
    Date Received
    December 21, 2005
    Date of Event
    December 9, 2005
    Report Date
    December 13, 2005
    Manufacturer
    TYCO HEALTHCARE/KENDALL
    Product Code
    MLN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES THAT IN 2005 "HE USED A SET OF DEFIB PADS WHERE THE STERNUM PAD WAS DELIVERING ENERGY BUT THE APEX PAD WAS NOT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1310P MEDITRACE 2/PK 20/CA DEFIBRILLATION PADS MLN TYCO HEALTHCARE/KENDALL 31319281 528016

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death