BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 1910494 · Received November 18, 2010

    Report

    Report Number
    3004209178-2010-09778
    Event Type
    Injury
    Date Received
    November 18, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 11, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT AND WAS NOTED TO HAVE HAD A STAPH INFECTION WITH THE NEUROSTIMULATOR. ADD'L INFO WAS REQUESTED.

    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 51 YR Required Intervention PROGRAMMER: MODEL 3031A, LOT# NGM019288P| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3889, LOT# V535651