BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFP II

    MDR report key: 119740 · Received July 11, 1997

    Report

    Report Number
    2017865-1997-00966
    Event Type
    Injury
    Date Received
    July 11, 1997
    Date of Event
    April 22, 1997
    Report Date
    April 15, 1997
    Manufacturer
    PACESETTER INC.
    Product Code
    DXY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    INFORMATION RECEIVED WITH RETURN OF THE EXPLANTED DEVICE NOTES THAT THE PATIENT DEMONSTRATED SYMPTOMS WHEN "HE HAD SLAPPED HI S SHOULDER LIGHTLY DURING A PLAYFUL DEMONSTRATION OF HOW HE FELT PRIOR TO HIS PACEMAKER IMPLANTATIOON." EVALUATION REVEALED A SLOW INTRINSIC RATE WITH NO PACING PRESENT. AN ATTEMPT TO INITIATE PACING WITH MAGNET APPLICATION WAS UNSUCCESSFUL.

    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 49 YR Required Intervention