BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARITY DDDR

    MDR report key: 372369 · Received January 10, 2002

    Report

    Report Number
    6000095-2002-00002
    Event Type
    Injury
    Date Received
    January 10, 2002
    Date of Event
    October 31, 2001
    Manufacturer
    VITATRON MEDICAL B.V.
    Product Code
    DXY
    Removal / Correction Number
    NI
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DAMAGED OR STRIPPED SETSCREW THREADS

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLARITY DDDR IMPLANTABLE PULSE GENERATOR DXY VITATRON MEDICAL B.V. 860 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other