BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 5211302 · Received November 9, 2015

    Report

    Report Number
    2124215-2015-13579
    Event Type
    Malfunction
    Date Received
    November 9, 2015
    Date of Event
    August 12, 2015
    Report Date
    August 17, 2015
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4); NO ADDITIONAL INFORMATION IS CURRENTLY AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE REMOTE HOME MONITORING SYSTEM ISSUED AN ALERT FOR HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS OF GREATER THAN 125 OHMS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONTACTED AND REVIEWED TRENDING DATA FOR THE SINGLE COIL RIGHT VENTRICULAR (RV) LEAD AND IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). UPON REVIEW IT WAS FOUND THAT THERE WAS A GRADUAL INCREASE FROM 80 OHMS TO 125 OHMS. TS DISCUSSED THAT IT WAS PHYSICIAN DISCRETION TO CONTINUE TO MONITOR THE LEAD OR BRING THE PATIENT IN FOR FURTHER EVALUATION. AT THIS TIME THE PHYSICIAN OPTED TO CONTINUE TO MONITOR THE PATIENT. THE RV LEAD AND ICD REMAIN IN SERVICE AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741212 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0293

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR 0293