BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3132575 · Received May 29, 2013

    Report

    Report Number
    3004209178-2013-08262
    Event Type
    Injury
    Date Received
    May 29, 2013
    Report Date
    May 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
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3889-28, LOT# VA005S0, IMPLANTED: (B)(6) 2013, 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 WAS EXPERIENCING A LOSS OF THERAPEUTIC EFFECT. A SHOCKING OR JOLTING SENSATION WAS NOTED. IT WAS NOTED THAT THE PATIENT HAD AN INJURY AT HER JOB "ABOUT 2 YEARS AGO". THE PATIENT HAD 12 WEEKS OF THERAPY AND WENT TO A SPECIALIST FOR 6 MONTHS AND WAS TOLD BY THE DOCTOR THAT "SOMETIMES WE SEE THIS OCCURENCE WHEN A PATIENT HAS A BACK INJURY". THE PATIENT STARTED HAVING PAIN "ABOUT A WEEK OR 2 AGO" SO SHE WENT TO THE HEALTHCARE PROVIDER, AND THEY PRESCRIBED THE PATIENT AN ANTIBIOTIC, "BUT I DONT HAVE AN INFECTION, I HAVE PAIN IN THE AREA WHERE THE WIRE IS, NOT AT THE IMPLANT SITE". THE PATIENT HAD PAIN IN THE BICYCLE SEAT AREA WHERE SHE HAD STIMULATION. THE MANUFACTURER'S REPRESENTATIVE TOLD THE PATIENT TO TURN AMPLITUDE DOWN, WHICH HELPED THE PAIN- BUT NOW THE PATIENT HAD A RETURN OF SYMPTOMS AND "THE FREQUENCY OF MY URINATION IS HORRIBLE". THE PATIENT COULD NOT SIT COMFORTABLY AND "HAS TO SIT TO THE SIDE AND USE CUSHIONS". THE TRIAL STIMULATION WENT FINE, BUT DURING THE PERMANENT IMPLANT SURGERY "THEY KIND OF PUSHED IT AND IT HURT AND I SAW OW! BUT THEN I WAS OK". THE PATIENT WAS "AT 4 SOMETHING AND NOW IS ON 3 SOMETHING AND I'M STILL HAVING PAIN AND IT'S NOT HELPING THE SYMPTOMS". THE PATIENT WAS ON PROGRAM 4 AT 4.3V. THEY CHANGED TO PROGRAM 1 AND IT WAS COMFORTABLE AT 2.7V. THE PATIENT WAS GOING TO TRY THIS SETTING. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235409 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention