BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 6659424 · Received June 21, 2017

    Report

    Report Number
    3004209178-2017-13479
    Event Type
    Malfunction
    Date Received
    June 21, 2017
    Date of Event
    May 24, 2017
    Report Date
    June 21, 2017
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A MANUFACTURER REPRESENTATIVE REPORTED AN IMPEDANCE ISSUE. THE REPRESENTATIVE NOTED THAT HE TESTED AT 1 V WITH THE FOLLOWING RESULTED C0 = 1356 OHMS AND 01, 02, 03 = > 4K OHMS. THE REPRESENTATIVE RETESTED AT 2V WITH C0 > 4K OHMS AND 01, 02, 03 = 2124 OHMS. THE REPRESENTATIVE WAS NO LONGER WITH THE CONSUMER, THE CONSUMER HAD NO COMPLAINTS ABOUT THE THERAPY, AND THE CONSUMER WAS FEELING STIMULATION AND GETTING SYMPTOM RELIEF. IT WAS REVIEWED TO INCREASE THE PULSE WIDTH (PW) TO 300 OR 360 TO GET MORE ACCURATE RESULTS. THE REPRESENTATIVE NOTED HE WOULD INCREASE PW WHEN HE SAW THE CONSUMER AGAIN. ADDITIONAL INFORMATION FROM THE REPRESENTATIVE REPORTED THE REPRESENTATIVE HAD NOT MET WITH THE CONSUMER AND SHE WAS DOING WELL. IT WAS NOTED THAT HER NEXT FOLLOW-UP APPOINTMENT WAS SCHEDULED FOR (B)(6) 2017. SINCE THE SYSTEM WAS WORKING WELL, ALL PROGRAMS FUNCTIONED PROPERLY AND THE CONSUMER WAS HAPPY THE REPRESENTATIVE FELT THAT THERE WAS NOTHING MORE TO DO. THERE WERE NO FURTHER COMPLICATIONS REPORTED AND/OR ANTICIPATED. ADDITIONAL INFORMA TION RECEIVED FROM THE REPRESENTATIVE ON (B)(6) 2017 NOTED THE CONSUMER¿S NEXT FOLLOW-UP APPOINTMENT IS SCHEDULED FOR (B)(6) 2017. NO TROUBLESHOOTING WAS PERFORMED AT THE TIME OF THE EVENT NOR THE CAUSE CAN BE DETERMINED. THE CONSUMER¿S SYMPTOMS HAVE BEEN RESOLVED AND SHE WAS CALLED BY THE DOCTOR¿S ADMIN AND SHE REPORTED SHE WAS DOING WELL AND HAPPY WITH THE SYSTEM. FURTHER INFORMATION RECEIVED FROM THE REPRESENTATIVE ON (B)(6) 2017 NOTED THE CONSUMER¿S NEXT FOLLOW-UP APPOINTMENT IS SCHEDULED FOR (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439308 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058

    Patients

    Seq Age Sex Outcome Treatment
    1