BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFP

    MDR report key: 103309 · Received March 10, 1997

    Report

    Report Number
    2017865-1997-00561
    Event Type
    Injury
    Date Received
    March 10, 1997
    Date of Event
    November 25, 1996
    Manufacturer
    PACESETTER INC.
    Product Code
    DXY
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    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 A CAPTURE ANOMALY AND THAT THE DEVICE APPEARED TO BE OPERATING IN THE VVI MODE.~~~~~~~~~

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AFP Implant IMPLANTABLE PACEMAKER PULSE GENERATOR DXY PACESETTER INC. 273 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 9 MO Required Intervention