BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISOLINE

    MDR report key: 5365808 · Received January 14, 2016

    Report

    Report Number
    1000165971-2016-00030
    Event Type
    Injury
    Date Received
    January 14, 2016
    Date of Event
    January 4, 2016
    Report Date
    January 7, 2016
    Manufacturer
    SORIN GROUP ITALIA S.R.L. - CRM FACILITY
    Product Code
    MRM
    PMA / PMN Number
    PP980049
    Removal / Correction Number
    Z-0928-2013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A STANDARD FOLLOW-UP ON (B)(6) 2016, IT WAS VERIFIED 3 WARNING MESSAGES: "[3] LOW SHOCK IMPEDANCE. DEFIBRILLATION SYSTEM INEFFECTIVE." "[48] MAX SHOCK ENERGY INEFFECTIVE ON (B)(6) 2016" "[46] HIGH SHOCK IMPEDANCE DETECTED ON (B)(6) 2016: DEFIBRILLATION SYSTEM INEFFECTIVE." NINE SHOCKS WERE DELIVERED, ALL OF THEM WITH STORED ENERGY = 41.9J AND DELIVERED ENERGY = 0J. THE SHOCK LEAD INTEGRITY TREND IS STABLE BETWEEN THE EXPECTED VALUES. IN THE MEMORIES OF THE DEVICE IT WAS ALSO NOTIFIED ATRIAL UNDERSENSING. THE PHYSICIAN CHANGED ATRIAL SENSIBILITY FROM 0.4 MV TO 0.2MV. IT WAS SCHEDULED A NEW FOLLOW-UP TO (B)(6) 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24648 ISOLINE DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER MRM SORIN GROUP ITALIA S.R.L. - CRM FACILITY ISOLINE 2CR6 2427

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention