BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITREL

    MDR report key: 2062846 · Received March 25, 2011

    Report

    Report Number
    3007566237-2011-02124
    Event Type
    Malfunction
    Date Received
    March 25, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 10, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ITREL MHY/GZF/GZB MHY MEDTRONIC NEUROMODULATION 3625 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 EXPLANTED:| IMPLANTED:| LEAD: MODEL LEAD URO, LOT# UNK