BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFP II

    MDR report key: 193747 · Received September 10, 1998

    Report

    Report Number
    2017865-1998-00829
    Event Type
    Injury
    Date Received
    September 10, 1998
    Date of Event
    June 6, 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
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INFORMATION RECEIVED WITH RETURN OF THE EXPLANTED DEVICE DOES NOT ADDRESS THE PATIENT'S CLINICAL STATUS BUT NOTES THAT THE DEVICE COULD NOT BE INTERROGATED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention