BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANTHEM RF

    MDR report key: 2240212 · Received September 9, 2011

    Report

    Report Number
    2017865-2011-05994
    Event Type
    Injury
    Date Received
    September 9, 2011
    Date of Event
    July 12, 2011
    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
    FL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. (B)(4) REVIEW OF QUALITY RECORDS.

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION. THE DEVICE WAS EXPLANTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention (B)(4), (B)(4), 7122, (B)(4), 1688, (B)(4)