BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSYNC MAXIMO

    MDR report key: 2171901 · Received September 13, 2006

    Report

    Report Number
    2171901
    Event Type
    Injury
    Date Received
    September 13, 2006
    Date of Event
    August 16, 2006
    Report Date
    August 23, 2006
    Manufacturer
    MEDTRONIC INC
    Product Code
    NIK
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING ROUTINE ICD CHECK ON (B)(6) 2006, THE DEVICE DEMONSTRATED ITS ERI (EARLY REPLACEMENT INDICATOR) DATED (B)(6) 2006. DEVICE WAS 14 MONTH OLD SUGGESTING PREMATURE BATTERY DEPLETION. ICD REPLACEMENT PERFORMED ON (B)(6) 2006 BY DR. (B)(6). "SAME TO DISH" COMPLETED PRIOR TO REPLACEMENT AND SENT TO MEDTRONIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSYNC MAXIMO IMPLANTABLE CARDIAC DEFIBRILLATOR NIK MEDTRONIC INC 7304

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention