BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3951205 · Received July 22, 2014

    Report

    Report Number
    2124215-2014-14254
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Date of Event
    June 12, 2014
    Report Date
    June 13, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 THIS RIGHT VENTRICULAR (RV) LEAD AND IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED HIGH  SHOCKING LEAD IMPEDANCE MEASUREMENTS GREATER THAN 125 OHMS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) PROVIDED TROUBLESHOOTING OPTIONS. ADDITIONAL INFORMATION INDICATED THAT NO INTERVENTION WAS PERFORMED AT THIS TIME AND 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
    428375 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0158

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR 1488T| 0158| T165| E163| A135