BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3040752 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-01522
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    January 1, 2013
    Report Date
    January 24, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS CURRENTLY AVAILABLE, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THAT THIS PATIENT'S HOME MONITORING SYSTEM DETECTED A LOW, OUT-OF-RANGE (OOR), SHOCK LEAD IMPEDANCE FOR THIS RIGHT VENTRICULAR (RV) LEAD AND CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM. AT THIS TIME, NO ADVERSE PATIENT EFFECTS WERE REPORTED AND ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE FIELD REPRESENTATIVE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS SEE BY THE PHYSICIAN AND A DEVICE EVALUATION WAS DONE. THE SHOCK IMPEDANCE WAS 59 OHMS AND THE ELECTROGRAMS (EGMS) WERE NORMAL. THE PHYSICIAN ELECTED TO CONTINUE TO MONITOR THE SYSTEM WITH THE REMOTE HOME MONITORING EQUIPMENT. NO INTERVENTION WAS PERFORMED OR IS BEING PLANNED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142988 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0158

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR 1860| E102| 0158