BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFP II

    MDR report key: 108435 · Received May 9, 1997

    Report

    Report Number
    2017865-1997-00746
    Event Type
    Injury
    Date Received
    May 9, 1997
    Date of Event
    January 23, 1997
    Manufacturer
    PACESETTER INC.
    Product Code
    DXY
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    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 OR REPROGRAMMED AND THAT THE MODE CHANGED FROM DDD TO VVI.~~~~~~~~

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AFP II Implant IMPLANTABLE PACEMAKER PULSE GENERATOR DXY PACESETTER INC. 283 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention