BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3922083 · Received July 9, 2014

    Report

    Report Number
    2124215-2014-13436
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    February 1, 2014
    Report Date
    June 19, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 VIA THE PATIENT REMOTE MONITORING SYSTEM THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT-OF-RANGE SHOCK LEAD IMPEDANCE (SLI) MEASUREMENT OF 129 OHMS. IMPEDANCE HAS BEEN TRENDING UPWARD OVER THE LAST FEW MONTHS; IT WAS 106 OHMS LAST FEBRUARY. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED TROUBLESHOOTING OPTIONS. ADDITIONAL INFORMATION WAS RECEIVED FROM THE FIELD REPRESENTATIVE THAT NO X-RAY WAS DONE AND WILL JUST MONITOR THE SITUATION AS THE PATIENT WAS IN INTENSIVE CARE UNIT (ICU). AT THIS TIME, THE SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401135 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0180

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR 0180| E102