BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3761268 · Received April 21, 2014

    Report

    Report Number
    2124215-2014-05704
    Event Type
    Malfunction
    Date Received
    April 21, 2014
    Date of Event
    March 3, 2014
    Report Date
    March 4, 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 THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED A LOW, OUT-OF-RANGE SHOCK IMPEDANCE MEASUREMENT WHICH WAS DETECTED THROUGH THE REMOTE MONITORING SYSTEM. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT SHOCK IMPEDANCE WAS CHRONICALLY LOW FOR THIS PATIENT. THE PHYSICIAN WAS ABLE TO CHECK THE DEVICE AND WAS GOING TO FOLLOW ON THIS PATIENT NORMALLY. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE SYSTEM REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240978 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR 0185| E110| 4480