BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYMMETRY DR

    MDR report key: 3925412 · Received January 15, 2014

    Report

    Report Number
    2017865-2014-08836
    Event Type
    Injury
    Date Received
    January 15, 2014
    Date of Event
    May 4, 2011
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    DXY
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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. EVALUATION DESCRIPTION INCLUDED. ANALYSIS CONFIRMED NORMAL BATTERY DEPLETION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR A FOLLOW UP. THE DEVICE EXHIBITED BACKUP VVI OPERATION. THE DEVICE WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38246 SYMMETRY DR IMPLANTABLE PACEMAKER PULSE GENERATOR, DXY DXY ST. JUDE MEDICAL, INC., CRMD 5360

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention