BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL

    MDR report key: 1851883 · Received October 4, 2010

    Report

    Report Number
    2124215-2010-14423
    Event Type
    Malfunction
    Date Received
    October 4, 2010
    Date of Event
    July 10, 2010
    Report Date
    July 10, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF TODAY, THIS PRODUCT HAS NOT BEEN RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THE PATIENT WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DEVICE SYSTEM WAS HOSPITALIZED BECAUSE HE RECEIVED NUMEROUS EPISODES OF SHOCK DELIVERY. AT THE HOSPITAL, DEVICE INTERROGATION REVEALED PACING IMPEDANCE MEASUREMENTS OF LESS THAN 200 OHMS AND POOR SENSING ON THE RIGHT VENTRICULAR (RV) NON-BOSTON SCIENTIFIC LEAD. ONE OF THE SHOCK EPISODES REVEALED A POSSIBLE SHORT CIRCUIT IN ASSOCIATION WITH THE VARIANCE IN SHOCK IMPEDANCE VALUES (<20; 125 OHMS). ADDITIONALLY, THERE WERE EPISODES OF NOISE ON THE RV CHANNEL, WHICH HAD BEEN INAPPROPRIATELY RECOGNIZED AS VT/VF, RESULTING IN THE INAPPROPRIATE SHOCK DELIVERY TO THE PATIENT. THE PHYSICIAN BELIEVED THE CRT-D BEHAVIOR WAS NORMAL, AND EVERYTHING WAS REPLACED THREE DAYS LATER WITHOUT FURTHER INCIDENT, DUE TO THE LEAD MALFUNCTION. THE DEVICE WILL NOT BE RETURNED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1