BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCENT DR RF

    MDR report key: 2014072 · Received March 10, 2011

    Report

    Report Number
    2017865-2011-01827
    Event Type
    Injury
    Date Received
    March 10, 2011
    Date of Event
    November 16, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DXY
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. REVIEW OF QUALITY RECORDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED A POCKET POCKET INFECTION. THE DEVICE WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCENT DR RF IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION PM2210 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention 2088TC/52, (B)(4), 2088TC/58, (B)(4)