BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3053136 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-04596
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 10, 2013
    Report Date
    January 12, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOCAL AREA SALES REPRESENTATIVE WAS CONTACTED FOR ADDITIONAL INFORMATION. AT THIS TIME, NO FURTHER INFORMATION IS AVAILABLE AND RECORDS INDICATE THESE PRODUCTS REMAIN IN SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    THE LOCAL AREA FIELD REPRESENTATIVE WAS CONTACTED FOR ADDITIONAL INFORMATION. AT THIS TIME, NO FURTHER INFORMATION IS AVAILABLE AND RECORDS INDICATE THIS SYSTEM REMAINS IN SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE DEFIBRILLATION LEAD AND CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED A HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT. REVIEW OF DAILY MEASUREMENTS SHOWED THE SHOCK IMPEDANCE MEASUREMENTS HAVE BEEN BETWEEN 90 AND 110 OHMS. ALL OTHER LEAD MEASUREMENTS WERE STABLE. A HEALTH CARE PROFESSIONAL (HCP) PLANNED TO SCHEDULE THE PATIENT FOR FURTHER EVALUATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THIS DEVICE AND LEAD CONTINUE TO EXHIBIT HIGH SHOCK IMPEDANCE MEASUREMENTS, INCLUDING OUT OF RANGE MEASUREMENTS. TECHNICAL SERVICES DISCUSSED THE PROGRAMMED SHOCKING VECTOR COULD RETURN HIGH SHOCK IMPEDANCE MEASUREMENTS. A HEALTH CARE PROFESSIONAL (HCP) PLANNED TO SCHEDULE THE PATIENT FOR FURTHER EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155043 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR 4592| N119| 0185| 4470