BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    META III

    MDR report key: 152680 · Received February 6, 1998

    Report

    Report Number
    2017865-1998-00016
    Event Type
    Malfunction
    Date Received
    February 6, 1998
    Date of Event
    January 1, 1997
    Report Date
    September 30, 1997
    Manufacturer
    TELECTRONICS PACING SYSTEMS INC
    Product Code
    DXY
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM THE FIELD DOES NOT ADDRESS THE PATIENT'S CLINICAL STATUS BUT NOTES THAT AT IMPLANT, THE DEVICE BEGA N TO PACE AT THE MAXIMUM RATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 META III Implant IMPLANTABLE PACEMAKER PULSE GENERATOR DXY TELECTRONICS PACING SYSTEMS INC 1206 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN