BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFP II

    MDR report key: 686615 · Received January 15, 2004

    Report

    Report Number
    2017865-1998-01042
    Event Type
    Injury
    Date Received
    January 15, 2004
    Date of Event
    June 25, 1998
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DXY
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    INFORMATION RECEIVED WITH RETURN OF THE EXPLANTED DEVICE NOTES THAT THE DEVICE WAS CAUSING THE PATIENT PAIN AT THE PACEMAKER SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AFP II IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 283 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention