BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3132721 · Received May 29, 2013

    Report

    Report Number
    3004209178-2013-08298
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Report Date
    February 8, 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
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3093-28, LOT# VA01AJ8, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT NEVER HAD THERAPEUTIC EFFECT AND WAS IN ¿LOTS OF PAIN¿. THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) REPORTEDLY HADN¿T HELPED WITH THE PATIENT¿S SYMPTOMS. THE REPORTER INDICATED THAT THE TRIAL WAS SUCCESSFUL BUT THE INS WAS NOT HELPING AND CAUSING PAIN IN THE BICYCLE SEAT AREA. IT WAS NOTED THAT THE PATIENT HAD STIMULATION UP TO 2.3V AND IT WAS PAINFUL. THE PAIN REPORTEDLY STARTED 2 MONTHS PRIOR TO THE REPORT AND THE PATIENT THOUGHT IT WOULD ¿LEVEL OUT¿ BUT IT HAD NOT. THE REPORTER STATED THAT THE PATIENT HAD TURNED STIMULATION DOWN BUT IT DIDN¿T WORK AND SHE WAS STILL ¿USING PADS EVERYDAY AND COULDN¿T MAKE IT TO THE BATHROOM¿. IT WAS ALSO NOTED THAT THE PATIENT WAS USING ¿DEPENDS¿ AT NIGHT ¿BECAUSE SHE WOKE UP SOAKED¿. TWO DAYS LATER, IT WAS REPORTED THAT THE PATIENT WAS STILL GETTING SHOCKING IN THE VAGINAL AREA. THE PATIENT¿S BACK REPORTEDLY HURT SO BAD SHE COULD HARDLY WALK. IT WAS ALSO NOTED THAT THE PATIENT COULD FEEL STIMULATION DOWN HER LEG. THE REPORTER INDICATED THAT STIMULATION HAD BEEN TURNED DOWN TO 1.9V BUT IT WAS NOT POSSIBLE TO GO LOWER. APPROXIMATELY 6 WEEKS LATER, IT WAS REPORTED THAT THE PATIENT WAS STILL HAVING CONCERNS REGARDING DEVICE OR THERAPY BUT WAS WORKING WITH A MANUFACTURER¿S REPRESENTATIVE OR HEALTHCARE PROVIDER (HCP). AN APPOINTMENT DATE OF (B)(6) 2013 WAS NOTED. IT WAS ALSO INDICATED THAT IT ¿DID NOT WORK¿. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. REFER TO MANUFACTURER'S REPORT # 3004209178-2013-03150 FOR ADDITIONAL PATIENT AND DEVICE INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235614 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1