BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 1812128 · Received August 17, 2010

    Report

    Report Number
    3004209178-2010-06174
    Event Type
    Malfunction
    Date Received
    August 17, 2010
    Date of Event
    January 1, 2010
    Report Date
    July 19, 2010
    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
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN STIMULATION WAS TURNED ON A SHOCKING OR JOLTING SENSATION AND PAIN NEAR THE TAILBONE SITE OCCURRED. IT WAS NOTED PT WORKED AT A RETAIL STORE AND STOOD NEAR A SECURITY GATE AND FELT SHOCKING SENSATIONS SEVERAL TIMES. IN ADDITION, PT STATED SHE LIFTED HEAVY PAINT CANS AND WONDERED IF SOMETHING HAPPENED TO THE LEAD THAT WOULD CAUSE THIS PAINFUL STIMULATION. PT WAS REDIRECTED TO HCP. AT THE TIME OF THIS REPORT, NO FURTHER INFO WAS PROVIDED. ADDITIONAL INFO HAD BEEN REQUESTED AND WILL BE PROVIDED WHEN AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM EZW MDT PUERTO RICO OPERATIONS CO., JUNCOS 3023 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR EXTENSION: MODEL 3095, LOT # NAH039893V| PROGRAMMER: MODEL 3031A, LOT # NGM032716P| EXPLANTED:| LEAD: MODEL 3889, LOT # V122743| EXPLANTED:| IMPLANTED,| IMPLANTED:| IMPLANTED:| EXPLANTED: