BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL

    MDR report key: 1944872 · Received January 3, 2011

    Report

    Report Number
    2124215-2010-19450
    Event Type
    Malfunction
    Date Received
    January 3, 2011
    Date of Event
    June 21, 2006
    Report Date
    October 4, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Removal / Correction Number
    Z-1192-06 THRU Z-1194-06
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS REMOVED, REPLACED AND RETURNED FOR ANALYSIS. ANALYSIS WAS PERFORMED AT OUR POST MARKET QUALITY ASSURANCE LABORATORY. PORTIONS OF THE CIRCUITRY, INCLUDING THE BATTERY, WERE ISOLATED AND TESTED. FINAL ANALYSIS CONCLUDED THAT THIS DEVICE HAD TWO COMPROMISED LOW-VOLTAGE CAPACITORS, WHICH RESULTED IN A HIGH CURRENT CONDITION. THIS ISSUE IS DISCUSSED IN THE (B)(6) 2010, PRODUCT PERFORMANCE REPORT. NO TEMPORARY LOSS OF RF TELEMETRY OCCURRED DURING BENCH TESTING.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) INAPPROPRIATELY DELIVERED ANTI-TACHYCARDIA PACING (ATP) FOR A NONSUSTAINED REPETITIVE ATRIAL TACHYCARDIA OF ALMOST 200 BEATS/MIN WITH 1:1 AV CONDUCTION. THE DEVICE ALSO DISPLAYED 180 EVENTS OF PMT (PACEMAKER MEDIATED TACHYCARDIA).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H195

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR (B)(4)| (B)(4)| (B)(4)| (B)(4)