BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2991590 · Received March 6, 2013

    Report

    Report Number
    3004209178-2013-03404
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Report Date
    February 13, 2013
    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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3889-28, LOT# VA01HA5, IMPLANTED: (B)(6) 2012. PRODUCT TYPE: LEAD: PRODUCT ID 3031A, SERIAL# (B)(4), IMPLANTED: (B)(6) 2002. PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED WHICH REPORTED THAT THE PATIENT RECEIVED ASSISTANCE FROM HER HEALTHCARE PROVIDER (HCP) OR MANUFACTURER¿S REPRESENTATIVE AND HER CONCERNS WERE RESOLVED. THE PATIENT WAS HOPING TO GET AN APPOINTMENT IN (B)(6). IT WAS ALSO INDICATED THAT THE PATIENT WAS STILL HAVING CONCERNS REGARDING DEVICE OR THERAPY BUT WAS WORKING WITH HER HCP OR MANUFACTURER¿S REPRESENTATIVE. IT WAS UNCLEAR IF THE PATIENT STILL HAD CONCERNS AND WHETHER OR NOT SHE HAD SOUGHT FURTHER HELP. OMITTED INFORMATION PERTAINING TO RELATED EVENT (B)(4) - LOSS OF EFFECT AND (B)(4): SEVERE DEPRESSION.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED WHEN THE PATIENT FELT SHOCKING THEY FELT IT IN THEIR VAGINAL AREA. THE PATIENT TURNED STIMULATION DOWN WITH THE PROGRAMMER AND THE SHOCKING STOPPED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE PATIENT FIRST GOT THE DEVICE LAST AUGUST, THE PATIENT WAS CLEANING AND "RAN INTO A DOOR", AND RECEIVED A SHOCKING SENSATION. THE REPORTER INDICATED THAT THIS WAS A ONE-TIME OCCURRENCE. NO FURTHER INFORMATION WAS REPORTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95646 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1