BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL TR

    MDR report key: 3070414 · Received April 22, 2013

    Report

    Report Number
    2124215-2013-06557
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 8, 2017
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    DTB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. A VISUAL INSPECTION OF THE DEVICE HEADER AND CASE NOTED NO ANOMALIES. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE DEFIBRILLATION, PACING, AND SENSING FUNCTIONS WERE TESTED. IMPEDANCE TESTING WAS COMPLETED AND ALL MEASUREMENTS WERE WITHIN NORMAL LIMITS. THE DEVICE OPERATED APPROPRIATELY WITH NO INTERRUPTIONS IN THERAPY OUTPUT AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WAS ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT AN ELECTROCARDIOGRAM (ECG) WAS PRESENTED TO THE LOCAL BOSTON SCIENTIFIC FIELD REPRESENTATIVE (FR) FOR THE PATIENT WITH THIS CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P). THE ECG SHOWED 2.5-3.0 SECOND PAUSE. THE FR DISCUSSED POSSIBLE CAUSES FOR THE OBSERVATION INCLUDING AN ISSUE WITH THE SURFACE PADS FOR THE ECG TO DEVICE ISSUES. THE FR REPORTED THEY WERE UNABLE TO UNCOVER A ROOT CAUSE FOR THE REPORTED OBSERVATION. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. THE DEVICE REMAINS IN SERVICE.

    Description of Event or Problem · 1

    SUBSEQUENT INFORMATION INDICATES THAT THIS DEVICE WAS EXPLANTED FOR NORMAL BATTERY DEPLETION. THE DEVICE WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172989 CONTAK RENEWAL TR IMPLANTABLE CHF GENERATOR DTB GUIDANT CRM CLONMEL IRELAND H120

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR H120| 4549