BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTAK RENEWAL

    MDR report key: 2171500 · Received July 21, 2011

    Report

    Report Number
    2124215-2011-10627
    Event Type
    Injury
    Date Received
    July 21, 2011
    Date of Event
    November 10, 2010
    Report Date
    June 7, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    PMA / PMN Number
    P010012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD WAS SURGICALLY ABANDONED AND THE DEVICE EXPLANTED OVER SIX MONTHS LATER AS IMPEDANCES WERE GREATER THAN 2000 OHMS. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, 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 THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR DETECTED A RISE OF IMPEDANCE FROM 700-1700 OHMS. A SAVE TO DISK WAS PERFORMED WHICH UNDERWENT ENGINEER ANALYSIS. ENGINEERS CONFIRMED THE IMPEDANCE RISE AND ALSO NOTED THAT THE THRESHOLDS HAD RISEN AND THE R-WAVES HAD ALSO DECREASED. IT WAS CONCLUDED THAT THERE COULD POTENTIALLY BE A LEAD, TISSUE, AND/OR TISSUE INTERFACE ISSUE AND IT WAS THE PHYSICIAN DISCRETION TO MONITOR OR INVESTIGATE FURTHER. IT WAS LATER REPORTED THAT AN ENGINEER HAD DISCUSSED THE POSSIBILITY OF CALCIFICATION AT THE ELECTRODE INTERFACE. 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 H210

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention 0185| 4470| H210| 4555