BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3043303 · Received April 9, 2013

    Report

    Report Number
    2124215-2013-02751
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    January 25, 2013
    Report Date
    October 12, 2013
    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

    ADDITIONAL INFORMATION WAS RECEIVED THAT ANOTHER ALERT WAS GENERATED FROM THE REMOTE HOME MONITORING SYSTEM FOR INTERMITTENT HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS. THE FIELD REPRESENTATIVE WAS UNABLE TO OBTAIN ADDITIONAL INFORMATION FROM THE CLINIC. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE REMOTE HOME MONITORING SYSTEM ISSUED AN ALERT FOR INTERMITTENT HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS ON THE RIGHT VENTRICULAR (RV) LEAD. THE CLINIC BROUGHT THE PATIENT IN FOR EVALUATION AND THE ALERT WAS CLEARED. NO FURTHER TROUBLESHOOTING WAS PERFORMED AND THE FIELD REPRESENTATIVE WAS UNABLE TO OBTAIN ANY ADDITIONAL INFORMATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145455 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0181

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR N119| 4543| 0181| 4136