BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTAK RENEWAL

    MDR report key: 2911785 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-16251
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    December 4, 2012
    Report Date
    January 22, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY THE DEVICE WAS RETURNED WITH MINOR SCRATCHES. ALL SEAL PLUGS WERE INTACT AND ALL SETSCREWS OPERATED NORMALLY. UPON FURTHER INTERROGATION IT WAS NOTED THAT THE DEVICE WAS IN FALLBACK MODE. A REVIEW OF THE DEVICE MEMORY NOTED NO FAULT CODES. AND ELECTRICAL MEASUREMENTS NOTED NORMAL SENSING, PACEMAKER, AND DEFIBRILLATION FUNCTIONS. LABORATORY ANALYSIS CONCLUDED THAT THE REASON THE DEVICE WENT INTO FALLBACK MODE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    UPON RETURN AND ANALYSIS THIS INVESTIGATION WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT WAS SHOCKED MANY TIMES FROM THE DEVICE. UPON ATTEMPTING TO INTERROGATE THE DEVICE AN ERROR MESSAGE WAS DISPLAYED THAT THE DEVICE WAS IN FALLBACK MODE. THE DEVICE WAS REPLACED DUE TO A POSSIBLE HIGH VOLTAGE CIRCUIT FAULT. THE DEVICE WILL BE RETURNED FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17769 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H195

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R