BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTAK RENEWAL

    MDR report key: 3211066 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-07470
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    April 19, 2013
    Report Date
    April 24, 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

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

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE CLINIC FOLLOW-UP VISIT CONDUCTED BY THE PHYSICIAN, THIS PATIENT PREVIOUSLY EXPERIENCED SYNCOPE DUE TO INHIBITION OF PACING. AN ASSOCIATED DEVICE REPORT INDICATED A DIVERTED THERAPY EPISODE, WITH NOISE ON THE RIGHT VENTRICULAR (RV) CHANNEL, AND ASYSTOLE (I.E. FLAT LINE) ON THE SHOCK CHANNEL. VALUES FOR THE PACING AND SHOCK IMPEDANCE MEASUREMENTS WERE WITHIN NORMAL RANGE. NOISE WAS NOT REPRODUCIBLE WHEN APPROPRIATELY TESTED. THE SYSTEM REMAINS IMPLANTED, BUT THE PHYSICIAN WILL PLAN TO REPLACE THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AS IT IS NEARING END OF LIFE. APPROXIMATELY ONE WEEK LATER, THE PHYSICIAN SURGICALLY ABANDONED AND REPLACED THE CHRONIC LEAD AND EXPLANTED THE DEVICE. THE DEVICE WAS DISCARDED AT THE HOSPITAL AND WILL NOT BE RETURNED. NEW PRODUCTS WERE SUCCESSFULLY IMPLANTED; THE DEVICE OF A NON-BOSTON SCIENTIFIC PRODUCT. NO ADDITIONAL ADVERSE EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310933 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H230

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R