BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIAMOND II DR

    MDR report key: 291841 · Received May 12, 2000

    Report

    Report Number
    2182208-2000-00140
    Event Type
    Malfunction
    Date Received
    May 12, 2000
    Date of Event
    October 28, 1999
    Manufacturer
    MEDTRONIC INC., CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DXY
    Removal / Correction Number
    NI
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    VENTRICULAR LEAD RESISTANCE GREATER THAN 3000 OHMS AT IMPLANT ATTEMPT. ANALYSIS AT VITATRON FOUND NO OUTPUT ON THE VENTRICLE CHANNEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIAMOND II DR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC INC., CARDIAC RHYTHM MANAGEMENT DIVISION 820 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other IMK49B IMPLANTABLE PACING LEAD| IMK49JB IMPLANTABLE PACING LEAD