BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROTHIN P-II BIPOLAR PULSE GENERATOR

    MDR report key: 120343 · Received September 8, 1997

    Report

    Report Number
    2124215-1997-02156
    Event Type
    Malfunction
    Date Received
    September 8, 1997
    Date of Event
    June 13, 1997
    Report Date
    June 13, 1997
    Manufacturer
    CARDIAC PACEMAKERS
    Product Code
    DXY
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    EVENT DESCRIPTION CPI RECEIVED INFORMATION THAT THIS IMPLANTABLE PULSE GENERATOR (IPG) WAS EXHIBITING A NO PACING CONDITION AND ERRATIC MAGNET RATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROTHIN P-II BIPOLAR PULSE GENERATOR Implant BIPOLAR IMPLANTABLE PULSE GENERATOR DXY CARDIAC PACEMAKERS 0623 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other THE DEVICE 4218/016634 WAS IMPLANTED 28-JUN-1984