BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2062838 · Received March 25, 2011

    Report

    Report Number
    3004209178-2011-02116
    Event Type
    Malfunction
    Date Received
    March 25, 2011
    Date of Event
    February 1, 2011
    Report Date
    March 10, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT EXPERIENCED A SHOCKING AND BURNING SENSATION AT THE NEUROSTIMULATOR LOCATION. SHE ALSO HAD A LOW-GRADE FEVER AND NOTED THAT THE SYMPTOMS HAD GOTTEN WORSE OVER THE PAST MONTH OR SO. THE PT WAS AT HOME IN GOOD CONDITION. ADDITIONAL INFORMATION 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 28 YR EXPLANTED:| PROGRAMMER: MODEL 3037, LOT# NJD111312N| LEAD: MODEL 3889, LOT# V492289| IMPLANTED: