BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTAK RENEWAL

    MDR report key: 3210821 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-10204
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    April 16, 2013
    Report Date
    October 10, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    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 THE HEADER WAS LOOSE AND LIFTED OFF THE CASE. MEDICAL ADHESIVE WAS PRESENT ON THE TOP OF THE CASE. ALL SETSCREWS MOVED FREELY AND OPERATED APPROPRIATELY IN BOTH DIRECTIONS. ANALYSIS DETERMINED THE LOOSE HEADER WAS CAUSED BY FORCE USED DURING THE EXPLANT PROCEDURE. ANALYSIS CONFIRMED THE BATTERY STATUS WAS BATTERY EXPIRED (BEX) AT THE TIME OF EXPLANT AND THE DEVICE HAD REVERTED TO STORAGE MODE.

    Additional Manufacturer Narrative · 1

    THIS DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS LOST TO FOLLOW-UP AND HAD PRESENTED DUE TO NOT FEELING WELL. INTERROGATION OF THE DEVICE REVEALED IT HAD REVERTED TO STORAGE MODE. AN INVASIVE PROCEDURE WAS PERFORMED TO REPLACE THE DEVICE. DURING THE PROCEDURE DIFFICULTY WAS EXPERIENCED REMOVING THE ATRIAL LEAD FROM THE DEVICE HEADER. THE LEAD WAS ABLE TO BE REMOVED FROM THE DEVICE HEADER, HOWEVER THE LEAD BODY STARTED TO SEPARATE. THE LEAD WAS SURGICALLY ABANDONED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311422 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H179

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| L| R H179| 4470| 0185