BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2040883 · Received March 18, 2011

    Report

    Report Number
    3004209178-2011-02080
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    February 8, 2011
    Report Date
    February 8, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    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 INTERSTIM II EZW MDT PUERTO RICO OPERATIONS CO., JUNCOS 3058 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 EXPLANTED:| LEAD: MODEL 3093, LOT# 0203993134| IMPLANTED: