BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARAGON III

    MDR report key: 152141 · Received February 6, 1998

    Report

    Report Number
    2017865-1997-01448
    Event Type
    Injury
    Date Received
    February 6, 1998
    Date of Event
    July 23, 1997
    Report Date
    September 3, 1997
    Manufacturer
    PACESETTER INC.
    Product Code
    DXY
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    INFORMATION RECEIVED WITH RETURN OF THE EXPLANTED DEVICE NOTES THAT THE PATIENT CAME INTO THE CLINIC WITH A SLOW, IRREGULAR P ULSE AROUND 50. WHEN THE PACEMAKER WAS INTER- ROGATED, THE MEASURED DATA SHOWED A LEAD IMPEDANCE OOF >1990 OHMS AND NO OUTPUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARAGON III Implant IMPLANTABLE PACEMAKER PULSE GENERATOR DXY PACESETTER INC. 2314L NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention