BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2913281 · Received January 14, 2013

    Report

    Report Number
    2124215-2013-00115
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Date of Event
    December 13, 2012
    Report Date
    January 4, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    --

    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 APPROXIMATELY ONE WEEK PRIOR TO THE PATIENT'S HOME MONITORING SYSTEM DETECTING THE OOR SHOCK LEAD IMPEDANCE, THE PATIENT HAD BEEN SEEN IN THE CLINIC FOR EVALUATION. AT THAT TIME, THE SHOCK LEAD IMPEDANCE MEASURED 118 OHMS. THE DEVICE CLINICIAN REPORTED THAT THE PATIENT WOULD CONTINUE TO BE MONITORED AND THAT ALL OTHER TESTS ON THE LEAD WERE NORMAL, AND THERE WERE NO VENTRICULAR EVENTS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20157 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0180

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR 4046| 4513| N119| 0180| 4086| T125| H210