BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL

    MDR report key: 2172805 · Received July 22, 2011

    Report

    Report Number
    2124215-2011-10159
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    June 10, 2011
    Report Date
    June 27, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF ANALYSIS, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    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 A COMPROMISED LOW-VOLTAGE CAPACITOR THAT DID NOT MEET DESIGN SPECIFICATION. DESPITE THIS COMPROMISED CAPACITOR, CURRENT LEAKAGE WAS NOT SUFFICIENT TO ADVERSELY IMPACT DEVICE LONGEVITY. NORMAL PACING, SENSING, AND DEFIBRILLATION THERAPY FUNCTIONS WERE VERIFIED DURING TESTING.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS RETURNED FOR DISPOSAL AFTER EXPLANT. NO PRODUCT PERFORMANCE ALLEGATIONS OR ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED WITH REGARD TO THIS DEVICE. ROUTINE INITIAL RETURNED DEVICE TESTING INDICATED THAT DETAILED ANALYSIS WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H170

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR 4473| 0184| H170| 4549| 4543| 1056T| N119