BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 5578475 · Received April 14, 2016

    Report

    Report Number
    3004209178-2016-07500
    Event Type
    Malfunction
    Date Received
    April 14, 2016
    Date of Event
    March 21, 2016
    Report Date
    May 23, 2016
    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

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A COMPANY REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR FOR URINARY DYS FUNCTION/SACRAL NERVE STIM AND GASTROINTESTINAL/PELVIC FLOOR . IT WAS REPORTED THAT THEY JUST IMPLANTED A NEW LEAD AND NEW IMPLANTABLE NEUROSTIMULATOR(INS). THEY WERE SEEING QUESTION MARK ON C-3 AND GREATER THAN 4000 OHMS ON ALL BIPOLAR PAIRS EXCEPT 2-3 (IMPEDANCE RAN AT 2.V,390 PW). IT WAS INDICATED THAT WHEN THEY TESTED MOTOR RESPONSE WITH JUST THE LEAD, THEY OBTAINED RESPONSE UNDER 1V ON ALL ELECTRODES. REP STATED THE SET SCREW WAS MISALIGNED IN THE HEADER BLOCK SO THEY HAD TO UNTIGHTEN SCREW AND RETIGHTEN IT, BUT WHEN THEY SCREWED IT IN, THE SCREW WAS CLICKING AS IF TIGHTEN ALL THE WAY AND THE LEAD WAS STILL LOOSE IN THE HEADER BLOCK. IT WAS INDICATED THAT THE INS WOULD NEED TO BE REPLACED AS THE SCREW WOULD NOT TIGHTEN PROPERLY AT THIS POINT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION FROM THE MANUFACTURERS' REPRESENTATIVE REPORTED THAT THE IMPEDANCE ISSUE RESOLVED HOWEVER; THE CAUSE WAS NOT DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232441 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR