BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL

    MDR report key: 2913682 · Received January 14, 2013

    Report

    Report Number
    2124215-2012-16997
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Date of Event
    December 19, 2012
    Report Date
    January 4, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RECEIVED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

    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

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PRODUCT WAS RETURNED WITH NO REPORTED PRODUCT PERFORMANCE ISSUES AND NO REPORTED ADVERSE PATIENT EFFECTS. INITIAL ANALYSIS COMPLETED IN OUR POST MARKET QUALITY ASSURANCE LABORATORY DETERMINED THIS PRODUCT DID NOT MEET LONGEVITY EXPECTATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20594 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H195

    Patients

    Seq Age Sex Outcome Treatment
    1 H195