BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARAGON II

    MDR report key: 152178 · Received February 6, 1998

    Report

    Report Number
    2017865-1997-01413
    Event Type
    Injury
    Date Received
    February 6, 1998
    Date of Event
    June 12, 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
    NZ
    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 PU LSE GENERATOR HAD PREMATURELY REACHED RECOMMENDED REPLACEMENT TIME (RRT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARAGON II Implant IMPLANTABLE PACEMAKER PULSE GENERATOR DXY PACESETTER INC. 2016T NA

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention