BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3824723 · Received May 21, 2014

    Report

    Report Number
    3004209178-2014-09381
    Event Type
    Malfunction
    Date Received
    May 21, 2014
    Report Date
    April 28, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3889-28, LOT# VA0E6YS, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE REPRESENTATIVE INDICATED A CASE WAS DONE ON (B)(6), STIMULATOR WAS MOVED FROM ONE SIDE TO THE OTHER. AT THE TIME OF PROCEDURE, THEY ALSO OPTED TO PLACE A NEW LEAD WIRE. WHEN PATIENT CAME BACK 10 DAYS LATER WAS ALL NORMAL. TODAY, PATIENT WAS BACK NOW AT CLINIC AND IMPEDANCES ARE OFF THE CHARTS (>4000OHMS). IMPEDANCES AT DEFAULT SETTINGS ARE AS FOLLOWS: C0 1004, C1 1004, C2 1037, C3 >4000OHMS, 01 NORMAL, 02 >4000, 03 >4000, 12 >4000, 13 >4000 AND 23 >4000. PATIENT REPORTS C+, 3- WAS ONLY ONE THEY GET BENEFIT FROM. ADDITIONAL INFORMATION RECEIVED REPORTED SOME OF THE HIGH IMPEDANCES DID RESOLVE WHEN THE PULSE WIDTH AND ENERGY WERE INCREASED AND TEST RUN AGAIN. THE REPRESENTATIVE WAS UNSURE EXACTLY WHAT THE RESULTS WERE AFTER THE IMPEDANCE TEST AND BELIEVED THERE WAS A REPROGRAMMING DONE TO EXCLUDE ANY ELECTRODES THAT SHOWED AN ERROR. CAUSE OF THE ISSUE WAS NOT DETERMINED. PATIENT DID INDICATE THAT SHE FELL IN HER GARDEN. IT WAS NOTED UNSURE OF THE CURRENT OUTCOME OF THE PATIENT AND ANY FUTURE INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301555 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00052 YR