BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

    MDR report key: 3890922 · Received January 13, 2014

    Report

    Report Number
    2938836-2014-03668
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    September 24, 2012
    Manufacturer
    ST. JUDE MEDICAL INC., CRMD
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFO PROVIDED BY MFR, NO MEDWATCH FORM WAS RECEIVED. THIS HISTORICAL COMPLAINT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF COMPLAINT FILES IN RESPONSE TO A RECENT FDA INSPECTION. THERE IS NO CHANGE TO THE ACTUAL PERFORMANCE OF THE PRODUCT AND THIS REPORT ONLY REPRESENTS AN ENHANCEMENT TO THE REPORTING CRITERIA GOING FORWARD. EVAL DESCRIPTION: THE REASONS FOR RETURN WERE "HELIX WOULD NOT EXTEND, THRESHOLD UNACCEPTABLE, AND LEAD IMPEDANCE (HV) HIGH". THE REASON FOR RETURN HELIX COULD NOT EXTEND WAS CONFIRMED DUE TO DRIED BODY FLUID IN AND ON THE INNER COIL. AFTER CLEANING THE HELIX COULD THE LEAD, THE HELIX COULD NOT BE EXTENDED. THE LEAD WAS CUT AT 10CM FROM THE HELIX WHERE ANALYSIS SHOWED DRIED BODY FLUID IN AND ON THE INNER COIL. TORQUE WAS TEN APPLIED TO THE INNER COIL, EXTENDING AND RETRACTING THE HELIX IN 3 REVOLUTIONS. THE COMPLAINT THRESHOLD UNACCEPTABLE AND LEAD IMPEDANCE (HV) HIGH COULD NOT BE CONFIRMED BECAUSE ELECTRICAL TESTS PERFORMED ON THE LEAD HAD NORMAL TEST RESULTS AND X-RAY ANALYSIS OF THE RV SHOCK COIL/CABLE SHOWED NO FRACTURE. THE HELIX EXTENSION MEASUREMENT WAS NORMAL AND WITHIN SPEC.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT ATTEMPT, THE PT HAD HIGH PACING AND DPT THRESHOLDS. DURING THE REPOSITIONING ATTEMPTS, THE HELIX WOULD NOT EXTEND NOR RETRACT. THE LEAD WAS RETURNED AND ANOTHER LEAD WAS IMPLANTED. NO ADVERSE EVENTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25631 DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR DEFIBRILLATOR LEAD NVY ST. JUDE MEDICAL INC., CRMD 7122Q/65

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR 7122Q/58, BNY014927| CD2311-36Q, 1023582| CD2231-40Q, 643138