BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIGOR DDD PULSE GENERATOR

    MDR report key: 69097 · Received January 9, 1997

    Report

    Report Number
    2124215-1997-00257
    Event Type
    Injury
    Date Received
    January 9, 1997
    Date of Event
    September 10, 1996
    Report Date
    September 10, 1996
    Manufacturer
    CARDIAC PACEMAKERS
    Product Code
    DXY
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    EVENT DESCRIPTION CPI RECEIVED INFORMATION THAT THIS IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXHIBITING INTERMITTENT LOSS OF CAPTURE. AN INVASIVE PROCEDURE WAS PERFORMED TO ANALYZE THE SYSTEM. THE SUTURE SLEEVE AREA OF THE VENTRICULAR LEAD, MODEL 4285, WAS FOUND TO HAVE INSULATION DAMAGE. THE LEAD WAS EXPLANTED. THE IPG REMAINS IMPLANTED AND IS FUNCTIONING APPROPRIATELY.

    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 UNKNOWN Required Intervention THE DEVICE 4285/203317 WAS IMPLANTED 26-AUG-1996| THE DEVICE 4269/231993 WAS IMPLANTED 26-AUG-1996