BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTAK RENEWAL

    MDR report key: 2041420 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-01150
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    May 27, 2010
    Report Date
    January 12, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    PMA / PMN Number
    P010012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THIS PRODUCT HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) RECORDED AN ATRIAL LEAD IMPEDANCE OF 2053 OHMS. IT WAS NOTED THAT THE PATIENT WAS IN ATRIAL FIBRILLATION/FLUTTER; THEREFORE, THE DEVICE WAS SET TO VVI MODE. THERE WAS NO EVIDENCE OF NOISE. IT WAS NOTED THAT THE LEAD WOULD CONTINUE TO BE MONITORED AND RE-EVALUATE WHEN THE DEVICE IS REPLACED IN THE FUTURE. TO DATE, THERE HAVE BEEN NO REPORTED ADVERSE PATIENT EFFECTS RELATED TO THIS CLINICAL OBSERVATION. ADDITIONAL INFORMATION WAS PROVIDED THAT THE DEVICE WAS LATER EXPLANTED DUE TO NORMAL BATTERY DEPLETION. HIGH ATRIAL THRESHOLDS WERE ALSO NOTED AT THE TIME OF EXPLANT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H170

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention H170| 0157| 1861| 4086| 4543| 4548| 4537