BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3675005 · Received March 12, 2014

    Report

    Report Number
    3004209178-2014-04315
    Event Type
    Malfunction
    Date Received
    March 12, 2014
    Report Date
    March 7, 2014
    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
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3093-28, LOT# V800432, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    ABOUT FIVE MONTHS PRIOR TO THE DATE OF THIS REPORT, IT WAS REPORTED THE PATIENT EXPERIENCED AN OVERSTIMULATION SENSATION. IT WAS STATED THAT THE PATIENT HAD A ¿TRIGGER POINT¿ IN HER VAGINA THAT WAS PAINFUL. THE PATIENT¿S DOCTOR TOLD HER TO TURN STIMULATION DOWN AND THAT RELIEVED THE PAIN. INFORMATION RECEIVED AS OF THE DATE OF THIS REPORT INDICATED THE PATIENT INITIALLY STATED THEY WERE NOT GOING TO USE STIMULATION ANYMORE BECAUSE THEY HAD A YOGA EXERCISE THEY WERE GOING TO DO. IT WAS NOTED THE PATIENT HAD A SURGICAL PROCEDURE ON THEIR SPINE OVER TWO MONTHS PRIOR WHERE THEY NEEDED TO TURN STIMULATION OFF. AFTER TURNING STIMULATION BACK ON THE PATIENT THOUGHT ¿IT WENT OFF¿ AGAIN. ABOUT A WEEK PRIOR TO THE DATE OF THE CALL, THE PATIENT STARTED HAVING PROBLEMS AND WAS GETTING WORSE. STIMULATION WAS SET AT 3.8V AND IT WAS STATED THAT IT WORKED FINE, BUT THE PATIENT KNEW IT WOULD START TO HURT ON THE LEFT SIDE EVENTUALLY AND THEY WOULD NEED TO TURN IT DOWN. THE PATIENT REPORTEDLY HAD GOTTEN NERVE PAIN FROM THE DEVICE ON THE SIDE OF THE VAGINA AND THAT IS WHY THEY TURNED IT DOWN. THE PATIENT WOULD LATER STATE THEY WERE UNSURE IF THE PAIN WAS FROM THE DEVICE OR SURGICAL PROCEDURE. DURING THE CALL, THE PATIENT WAS ABLE TO DECREASE FROM 3.8V TO 1.5V. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT DID NOT HAVE CONCERNS WITH THEIR DEVICE OR THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147351 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1