BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3050162 · Received April 10, 2013

    Report

    Report Number
    2124215-2013-05516
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    February 18, 2013
    Report Date
    November 5, 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.

    Description of Event or Problem · 1

    FURTHER INFORMATION WAS RECEIVED THAT ADDITIONAL OUT OF RANGE, SHOCK LEAD IMPEDANCE MEASUREMENTS WERE DETECTED. THE HEALTH CARE PROFESSIONAL (HCP) REPORTED THEY ARE AWARE OF THE ISSUE AND ARE MONITORING. AT THIS TIME, THE SYSTEM REMAINS IN SERVICE AND THERE HAVE BEEN NO ADVERSE PATIENT EFFECTS REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT'S HOME MONITORING SYSTEM DETECTED A HIGH, OUT-OF-RANGE (OOR), SHOCK LEAD IMPEDANCE FOR THIS RIGHT VENTRICULAR (RV) LEAD AND CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE FIELD REPRESENTATIVE (REP) CONTACTED THE CLINIC AND WAS TOLD THAT PATIENT HAD BEEN SEEN IN THE CLINIC, BUT NO FURTHER INFORMATION WAS PROVIDED TO THE REP. AT THIS TIME, EVIDENCE SUGGESTS THAT THE SYSTEM REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149586 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0292

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR E142| 0292| 4135| 5076| 7288| 6949