BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1871075 · Received October 15, 2010

    Report

    Report Number
    2124215-2010-17083
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    August 24, 2010
    Report Date
    September 30, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RETURN, THIS LEAD WAS THOROUGHLY ANALYZED. ENGINEERS CONFIRMED A COMPLETE LEAD WITH AN EXTENDED HELIX; TISSUE ENGAGED WITHIN THE MIDDLE SECTION OF THE HELIX BASE. HELIX MECHANISM TESTING IN THE RETURNED CONDITION FAILED TO FUNCTION AS DESIGNED; HOWEVER, AFTER TISSUE REMOVAL, COMPLETE EXTENSION AND RETRACTION CAPABILITY WAS CONFIRMED TO BE FUNCTIONING NORMALLY. EXTENSIVE TESTING WAS THEN PERFORMED TO ASSESS THE LEAD'S ELECTRICAL AND INSULATION INTEGRITY. MEASUREMENTS THROUGHOUT THESE TESTS DEMONSTRATED CONTINUITY OF THE ELECTRICAL CIRCUITRY AND THE LEAD INSULATION. RIGOROUS TESTING, INCLUDING EXTENSIVE LEAD MANIPULATION WHILE CONNECTED TO AN OHMMETER, VERIFIED THERE WAS NO INTERMITTENCY IN THE ELECTRICAL CONDUCTIVITY.

    Additional Manufacturer Narrative · 1

    BOSTON SCIENTIFIC, CRM WILL ANALYZE THIS DEVICE UPON RECEIPT AND PROVIDE ADDITIONAL INFORMATION ONCE THE TESTING HAS BEEN COMPLETED AND AN UPDATED REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV), DEFIBRILLATION LEAD EXHIBITED HIGH PACING THRESHOLDS THREE MONTHS POST-IMPLANT SO A REVISION PROCEDURE WAS SCHEDULED. (PACING INHIBITION WAS OBSERVED JUST BEFORE THE REVISION PROCEDURE AT 7.5 @ 1.0 MS ALTHOUGH NO ASYSTOLE RESULTED.) DURING THE REVISION PROCEDURE, THE FIXATION TOOL WAS UNABLE TO RETRACT THE HELIX; TWO FIXATION TOOLS WERE ATTEMPTED, AN OLDER AND NEWER MODEL. AFTER 50-60 TURNS, THE HELIX RETRACTED. THE PHYSICIAN ALSO EXPERIENCED ISSUES EXTRACTING THE LEAD ALTHOUGH IT WAS EVENTUALLY REMOVED. AFTER THE LEAD WAS EXPLANTED, THE PHYSICIAN TESTED THE HELIX BY TRYING TO EXTEND IT AND REPORTED ONGOING PROBLEMS. AFTER 20 TURNS, THE HELIX SUDDENLY POPPED OUT OF THE DISTAL END OF THE LEAD DESPITE THE FACT THAT THE PHYSICIAN WAS TURNING THE FIXATION TOOL SLOWLY. A NEW LEAD WAS IMPLANTED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0293

    Patients

    Seq Age Sex Outcome Treatment
    1 F103| 0293