BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROTHIN P-II UNIPOLAR PULSE GENERATOR

    MDR report key: 143203 · Received November 7, 1997

    Report

    Report Number
    2124215-1997-02890
    Event Type
    Malfunction
    Date Received
    November 7, 1997
    Date of Event
    September 25, 1997
    Report Date
    September 25, 1997
    Manufacturer
    CARDIAC PACEMAKERS
    Product Code
    DXY
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    EVENT DESCRIPTION CPI RECEIVED INFORMATION THAT THIS IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED A SENSING ANOMALY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROTHIN P-II UNIPOLAR PULSE GENERATOR Implant UNIPOLAR IMPLANTABLE PULSE GENERATOR DXY CARDIAC PACEMAKERS 0523 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Other THE DEVICE 4150/010920 WAS IMPLANTED 02-OCT-1984| THE DEVICE 4150/010415 WAS IMPLANTED 26-SEP-1984