BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3914076 · Received July 3, 2014

    Report

    Report Number
    3004209178-2014-12537
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Report Date
    June 12, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 3889-28, LOT# V536705, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPEDANCE READINGS WERE >4000 ON ALL BIPOLAR PAIRS AND >4000 ON ALL OR SOME OF THE UNIPOLAR PAIRS. THE PATIENT WAS AT THEIR DOCTOR¿S OFFICE AT THE TIME OF THE REPORT FOR REPROGRAMMING. CONTACT 3 WAS THE ONLY ONE NOT SHOWING >4000 OHMS AS IT WAS AT 745 OHMS. THE LAST INTERROGATION WAS ON MARCH 2013 AND THE ONLY PAIR SHOWING >4000 OHMS WAS CONTACTS 1 AND 2. CONTACTS 1 AND 2 ALSO SHOWED >4000 OHMS IN 2012. THE PATIENT WAS IN A WHEELCHAIR AND HAD FALLEN SEVERAL TIMES IN BED. THE PATIENT¿S DEVICE WAS CHANGED TO CONTINUOUS AND THE PULSE WIDTH WAS INCREASED. THE PATIENT HAD FELT IT IN THEIR BUTTOCKS AREA AND BY INCREASING THE PULSE WIDTH THEY WERE ABLE TO FEEL A DIFFERENT FLUTTERING. IT WAS ALSO NOTED THAT THERE WAS CYCLING. IT WAS FURTHER REPORTED THAT CONTACT 3 SHOWED 1004 OHMS. THE CAUSE OF THE IMPEDANCE ISSUE WAS DETERMINED TO BE MULTIPLE FALLS. THERE WAS NO TROUBLESHOOTING DONE. APPOINTMENT DATES OF (B)(6) WERE NOTED. THE PATIENT WAS DOING FINE AT THE TIME OF THE REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391396 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1