BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3921701 · Received July 9, 2014

    Report

    Report Number
    2124215-2014-11499
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 13, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 PATIENT'S REMOTE MONITORING SYSTEM THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WITH THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT-OF-RANGE (OOR) SHOCK LEAD IMPEDANCE. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) RECOMMENDED BRINGING PATIENT IN. FURTHER, ANOTHER HIGH OOR SHOCK LEAD IMPEDANCE WAS DETECTED VIA PATIENT'S REMOTE MONITORING SYSTEM. ADDITIONAL INFORMATION RECEIVED AND INDICATED THAT THE CAUSE WAS UNDETERMINED AND THE PHYSICIAN WAS CONSIDERING BRINGING PATIENT FOR X-RAY OR OTHERWISE THE CLINIC WILL CONTINUE TO MONITOR LEAD. THE SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400225 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0293

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR 0293| E160