BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIGOR DDD PULSE GENERATOR

    MDR report key: 73776 · Received January 16, 1997

    Report

    Report Number
    2124215-1997-00594
    Event Type
    Injury
    Date Received
    January 16, 1997
    Date of Event
    October 23, 1996
    Report Date
    October 28, 1996
    Manufacturer
    CARDIAC PACEMAKERS
    Product Code
    DXY
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    EVENT DESCRIPTION CPI RECEIVED INFORMATION THAT THIS IMPLANTABLE PULSE GENERATOR (IPG) WAS EXPLANTED DUE TO UNDERSENSING. A NEW IPG WAS IMPLANTED AND WORKED PROPERLY.

    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 66 YR Required Intervention THE DEVICE 0950/294761 WAS IMPLANTED 28-OCT-1996