BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 4276767 · Received November 25, 2014

    Report

    Report Number
    3004209178-2014-22170
    Event Type
    Malfunction
    Date Received
    November 25, 2014
    Report Date
    November 4, 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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3037, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3 093-33 ,LOT# V833270, IMPLANTED: 2011 (B)(6); PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS NOT ABLE TO MAKE ADJUSTMENT BOTH WITH AND WITHOUT THE ANTENNA ATTACHED TO THE PATIENT PROGRAMMER. THE PATIENT HADN¿T USED THEIR DEVICE FOR ABOUT A YEAR AND FORGOT ABOUT IT AND THEIR UROLOGIST TOLD THEM TO START USING IT AGAIN AND INCREASE IT. ALL THE PATIENT GOT WAS THE SCREEN SAYING IT WAS TRYING TO COMMUNICATE AND THEN POOR CONNECTION. THE PATIENT TRIED PUTTING NEW BATTERIES IN THE PROGRAMMER. THE PATIENT¿S PROBLEMS STARTED IN 1981 AND THE DEVICE SEEMED TO WORK GREAT AND CORRECTED THE PROBLEM FOR A WHILE AND THEN THE PROBLEM STARTED AGAIN. THE PATIENT GOT POOR COMMUNICATION WITH AND WITHOUT THE ANTENNA ATTACHED TO THE PROGRAMMER. THE PROGRAMMER WOULD ONLY BEEP. NO PATIENT INJURY WAS REPORTED. THE NEXT DAY IT WAS REPORTED THAT THE PATIENT WAS STILL NOT ABLE TO MAKE ADJUSTMENT BOTH WITH OR WITHOUT THE ANTENNA ATTACHED. THEY GOT THE REPLACEMENT PROGRAMMER BUT STILL COULDN¿T CONNECT WITH THE IMPLANTABLE NEUROSTIMULATOR (INS). THE PATIENT NOTICED SYMPTOM CHANGE SINCE ABOUT 2 MONTHS AGO. THEY HAD THE URGE TO GO BUT VERY LITTLE WAS THERE. NO OUTCOME OR INTERVENTIONS WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764818 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1