BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIGOR DDD PULSE GENERATOR

    MDR report key: 69094 · Received January 9, 1997

    Report

    Report Number
    2124215-1997-00254
    Event Type
    Malfunction
    Date Received
    January 9, 1997
    Date of Event
    September 9, 1996
    Report Date
    September 9, 1996
    Manufacturer
    CARDIAC PACEMAKERS
    Product Code
    DXY
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    EVENT DESCRIPTION CPI RECEIVED A FAX ALLEGING THAT THIS IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED A LOSS OF CAPTURE WHEN PROGRAMMED IN THE BIPOLAR MODE, HOWEVER IT FUNCTIONS APPROPRIATELY WHEN PROGRAMMED TO THE UNIPOLAR MODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIGOR DDD PULSE GENERATOR Implant IMPLANTABLE PULSE GENERATOR DXY CARDIAC PACEMAKERS 0950 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Other THE DEVICE 4285/200796 WAS IMPLANTED 10-NOV-1995| THE DEVICE 4269/232856 WAS IMPLANTED 10-NOV-1995