BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT CONVERTER

    MDR report key: 1901596 · Received November 12, 2010

    Report

    Report Number
    2953200-2010-02219
    Event Type
    Injury
    Date Received
    November 12, 2010
    Date of Event
    October 14, 2010
    Report Date
    October 14, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL RESULTS AND CONCLUSION: (SEVERELY TORTUOUS AND CALCIFIED VESSELS).

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT CONVERTER MIH MEDTRONIC CARDIOVASCULAR GALWAY NA V00392210

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention