BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANTHEM RF

    MDR report key: 3218428 · Received July 10, 2013

    Report

    Report Number
    2017865-2013-03722
    Event Type
    Injury
    Date Received
    July 10, 2013
    Date of Event
    April 22, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DXY
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED SYNCOPE. THE PULSE GENERATOR EXHIBITED PREMATURE DISCHARGE OF BATTERY. THE DEVICE WAS EXPLANTED AND REPLACED ON 04/23/2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316368 ANTHEM RF IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION PM3210 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention MEDTRONIC 5076, (B)(4)