BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3609432 · Received February 5, 2014

    Report

    Report Number
    3004209178-2014-01640
    Event Type
    Malfunction
    Date Received
    February 5, 2014
    Report Date
    January 16, 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

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3093-33, LOT# V833270, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT BELIEVED THAT THE LEAD HAD MOVED AGAIN. IT WAS NOTED THAT THE PATIENT HAD CONSTANT BURNING AND URGENCY BUT SHE DIDN¿T HAVE TO GO. IT WAS NOTED THAT THIS HAD HAPPENED BEFORE AND THE PATIENT HAD FELT THE EXACT SAME WAY. SEE MFR. REPORT #3004209178-2014-01639 FOR INFORMATION ABOUT THE PATIENT¿S PREVIOUS EXPERIENCE. THE REPORTER STATED THAT IT STARTED AT ¿THIS SEVERITY¿ THE DAY PRIOR TO THE REPORT BUT IT WAS POSSIBLE THAT IT WAS LESS SEVERE EARLIER. IT WAS REPORTED THAT THE PATIENT HAD A LOT OF BLADDER PROBLEMS SO IT WAS HARD TO TELL. IT WAS NOTED THAT THE PATIENT HAD ¿OTHER BLADDER ISSUES¿ AND HAD SURGERY IN (B)(6) 2013. IT WAS REPORTED THAT THE PATIENT HAD NO FALLS, TRAUMA, OR NEW ACTIVITIES ADDED, BUT THE PATIENT WAS VERY ACTIVE SO IT WAS POSSIBLE SHE ¿MIGHT HAVE DONE SOMETHING.¿ IT WAS NOTED THAT THE PATIENT HAD NOT HAD A MEDICAL PROCEDURE BUT DID HAVE A NERVE BLOCK IN THE RIGHT SIDE OF THE SPINE FOR SCIATIC PAIN THAT WAS PERFORMED ONE MONTH PRIOR TO THE REPORT. THE REPORTER STATED THAT THE PATIENT HAD AN APPOINTMENT TO SEE A UROLOGIST ON (B)(6) 2014 BUT SHE COULDN¿T WAIT UNTIL THE PAIN WAS SO SEVERE SHE COULDN¿T SLEEP, AND SHE WENT TO THE EMERGENCY ROOM THE EVENING PRIOR TO THE REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75709 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1