BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

    MDR report key: 4172458 · Received January 13, 2014

    Report

    Report Number
    2938836-2014-01777
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC. CRMD
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFO PROVIDED BY MANUFACTURER, 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 GOOD FORWARD. EVALUATION DESCRIPTION: MULTIPLE BENT/KINKS WERE NOTED ON STYLET. VISUAL EXAMINATION OF THE LEAD FOUND IT WAS BENT/KINKED AT THE HELIX SHAFT AREA. X-RAY CONFIRMED DISTAL COIL WAS DAMAGED AT HELIX SHAFT AREA. HELIX COULD BE EXTENDED/RETRACTED WITHIN 25 TURNS, BUT NOT SMOOTHLY, BECAUSE OF DISTAL COIL DAMAGE AT HELIX SHAFT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO IMPLANT THE HELIX WOULD NOT EXTEND OR RETRACT. THIS LEAD WAS NOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28245 DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR DEFIBRILLATION LEAD, NVY NVY ST. JUDE MEDICAL, INC. CRMD 7122Q/65

    Patients

    Seq Age Sex Outcome Treatment
    1