BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2558486 · Received May 3, 2012

    Report

    Report Number
    3004209178-2012-02944
    Event Type
    Malfunction
    Date Received
    May 3, 2012
    Report Date
    April 11, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3093-33 LOT# V871804 IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD, PRODUCT ID 3037 SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS A SHOCKING OR JOLTING SENSATION IN THE PATIENT'S VAGINA. THE PATIENT WAS GETTING SHOCKED WHEN SHE ENTERED AND LEFT THE STORE AT SEVERAL DEPARTMENT STORES. THE ISSUE MAINLY OCCURRED AT STORES THAT HAD 'LARGE' SECURITY GATES. THE DEVICE WAS TURNED ON WHEN PASSING THROUGH THE SECURITY GATES. IT WAS RECOMMENDED TO TURN THE DEVICE OFF WHEN PASSING THROUGH THE GATES, HOWEVER THE REPORTER STATED IT WAS A PAIN TO TURN THE DEVICE OFF EACH TIME. IT WAS NOTED THE PATIENT HAD NO OTHER CONCERNS WITH DEVICE BESIDES THE SHOCKING WHEN GOING THROUGH SECURITY GATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1