BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZEPHYR XL DR

    MDR report key: 4192253 · Received January 13, 2014

    Report

    Report Number
    2017865-2014-04115
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    August 10, 2012
    Manufacturer
    ST. JUDE MEDICAL, CRMD
    Product Code
    LWP
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFO WAS 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 REPORTED FIELD EVENT OF DIFFICULTY TIGHTENING SETSCREW WAS CONFIRMED IN THE LABORATORY. THE UPPER PART OF THE ATRIAL HEX INSET WAS STRIPPED AND EXCESSIVE MEDICAL ADHESIVE INSIDE THE ATRIAL HEX INSET WAS FOUND. AFTER REMOVAL OF THE MEDICAL ADHESIVE THE ATRIAL SETSCREW COULD BE RETRACTED AND RETIGHTENED. THE EXCESSIVE MEDICAL ADHESIVE WAS ADDED DURING MFG.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATRIAL SETSCREW WAS UNABLE TO TIGHTEN DURING IMPLANT. THE ATRIAL SCREW WOULD NOT RATCHET. THE DEVICE WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32124 ZEPHYR XL DR IMPLANTABLE PACEMAKER PULSE GENERATOR LWP ST. JUDE MEDICAL, CRMD 5826

    Patients

    Seq Age Sex Outcome Treatment
    1