BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPHYR XL DR

    MDR report key: 4142992 · Received January 13, 2014

    Report

    Report Number
    2017865-2014-05605
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    December 19, 2011
    Manufacturer
    ST. JUDE MEDICAL, CRMD
    Product Code
    DXY
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT PRESENTED IN CLINIC FOR A FOLLOW UP. UPON INTERROGATION AN ERROR MESSAGE DISPLAYED INFORMING THE USER THE DIAGNOSTIC DATA WAS INVALID. THE PULSE GENERATOR EXHIBITED BACKUP VVI OPERATION. IT WAS CLINICALLY RESOLVED BY REPROGRAMMING. THE DEVICE REMAINED IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31623 EPHYR XL DR IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST. JUDE MEDICAL, CRMD 5826

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR