BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3760918 · Received April 21, 2014

    Report

    Report Number
    2124215-2014-08902
    Event Type
    Malfunction
    Date Received
    April 21, 2014
    Date of Event
    September 1, 2013
    Report Date
    March 28, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    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 PATIENT IMPLANTED WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD RECEIVED A CHECK RV LEAD MESSAGE DURING AN IN-CLINIC CHECK. A RISING RV PACE IMPEDANCE MEASUREMENT WAS NOTED PER DAILY MEASUREMENTS TREND. ALSO, ELEVATED THRESHOLD VALUES WERE NOTED ALONG WITH A STABLE SHOCKING LEAD IMPEDANCE MEASUREMENT. NO NOISE COULD BE RECREATED ON ISOMETRICS AND POCKET MANIPULATIONS. APPROXIMATELY A WEEK LATER, HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS WERE OBSERVED. ADDITIONAL INFORMATION INDICATED THAT THE PATIENT WILL CONTINUE TO BE MONITORED. THE SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239835 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0184

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR E141| MISMATCH| 0184