BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISTA DDD PULSE GENERATOR

    MDR report key: 73965 · Received January 16, 1997

    Report

    Report Number
    2124215-1997-00726
    Event Type
    Injury
    Date Received
    January 16, 1997
    Date of Event
    November 22, 1996
    Report Date
    November 22, 1996
    Manufacturer
    CARDIAC PACEMAKERS
    Product Code
    DXY
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    EVENT DESCRIPTION CPI RECEIVED INFORMATION THAT DURING ROUTINE TESTING OF THIS IMPLANTABLE PULSE GENERATOR (IPG), THE MAGNET RATE WAS FOUND TO BE 25 BEATS PER MINUTE, AND THE IPG WOULD NOT PERFORM ANY MEASUREMENTS. THE IPG ALSO EXHIBITED INTERMITTENT LOSS OF CAPTURE. THE IPG WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISTA DDD PULSE GENERATOR Implant IMPLANTABLE PULSE GENERATOR DXY CARDIAC PACEMAKERS 0940 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention THE DEVICE 0041/142801 WAS IMPLANTED 07-OCT-1991| THE DEVICE 0041/142802 WAS IMPLANTED 07-OCT-1991| THE DEVICE 1550/693623 WAS IMPLANTED 07-OCT-1991