BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCENT SR

    MDR report key: 3925681 · Received July 10, 2014

    Report

    Report Number
    2017865-2014-15226
    Event Type
    Malfunction
    Date Received
    July 10, 2014
    Date of Event
    May 1, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    DXY
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PULSE GENERATOR WAS INTERROGATED WHILE STILL IN THE BOX. THE DEVICE EXHIBITED BACKUP OPERATION. THE DEVICE WAS NOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404855 ACCENT SR IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST. JUDE MEDICAL, INC., CRMD PM1110 NA

    Patients

    Seq Age Sex Outcome Treatment
    1