BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTAK RENEWAL

    MDR report key: 1864248 · Received October 11, 2010

    Report

    Report Number
    2124215-2010-16148
    Event Type
    Injury
    Date Received
    October 11, 2010
    Date of Event
    August 5, 2010
    Report Date
    August 5, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    PMA / PMN Number
    P010012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME THE DEVICE HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC, CRM FOR ANALYSIS. THERE IS NO ADDITIONAL INFORMATION AVAILABLE. IF FURTHER INFORMATION BECOMES AVAILABLE, THIS EVENT WILL BE REOPENED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND IMPLANTABLE RIGHT VENTRICULAR (RV) LEAD WERE EXHIBITING NOISE ON THE RV CHANNEL. THE NOISE WAS OVERSENSED WHICH RESULTED IN PACING INHIBITION AND THE DELIVERY OF FIVE INAPPROPRIATE SHOCKS. THE PATIENT WAS PACEMAKER DEPENDENT AND REPORTED MULTIPLE SYNCOPAL EPISODES. A REVISION PROCEDURE TOOK PLACE AND THE RV LEAD WAS SURGICALLY ABANDONED. THE PACE/SENSE PORTION OF THE CHRONIC RV DEFIBRILLATION LEAD WAS PUT INTO SERVICE. THE DEVICE WAS ALSO EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H219

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Life Threatening| R H219| H125| 4554| 4518| 4088| 0185| N119