BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL

    MDR report key: 2052708 · Received April 13, 2011

    Report

    Report Number
    2124215-2011-04391
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    February 24, 2011
    Report Date
    March 21, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS UNDERGOING ANALYSIS. UPON COMPLETION OF ANALYSIS, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST-MARKET QUALITY ASSURANCE LABORATORY, A LONGEVITY CALCULATION CONFIRMED THAT THE DEVICE DID NOT MEET LONGEVITY ESTIMATES PROVIDED IN DEVICE LABELING. PORTIONS OF THE CIRCUITRY, INCLUDING THE BATTERY, WERE ISOLATED AND TESTED. FINAL ANALYSIS CONCLUDED THAT THE PREMATURE BATTERY DEPLETION WAS DUE TO LOW-VOLTAGE CAPACITOR DEGRADATION, WHICH RESULTED IN A HIGH CURRENT CONDITION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS NON-COMPLIANT AND LOST TO FOLLOW UP EVALUATIONS. UPON INTERROGATION, THE DEVICE WAS FOUND IN STORAGE MODE. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND A CHANGE OUT PROCEDURE WAS PERFORMED AND THE DEVICE WAS EXPLANTED AND RETURNED FOR ANALYSIS. INITIAL ANALYSIS INDICATED THAT FURTHER ANALYSIS WAS NECESSARY. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H175

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR 4046| 0185| 4518| 4402| H175| (B)(4)