BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3604384 · Received February 3, 2014

    Report

    Report Number
    3004209178-2014-01515
    Event Type
    Malfunction
    Date Received
    February 3, 2014
    Report Date
    January 13, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3093-28, LOT# V926162, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS HAVING A PROBLEM WITH THERAPY AND HAD A RETURN OF SYMPTOMS AND A LOSS OF THERAPEUTIC EFFECT FOR ABOUT TWO MONTHS. IT WAS NOTED THAT THE PATIENT WAS NOT FEELING STIMULATION FOR ABOUT TWO MONTHS. THE REPORTER STATED THAT THE PATIENT FELL IN EARLY OCTOBER AND EARLY DECEMBER AND SINCE THEN THERAPY HAD NOT BEEN WORKING AS WELL. IT WAS REPORTED THAT PRIOR TO TWO MONTHS AGO THE THERAPY WAS PROVIDING RELIEF. IT WAS NOTED THAT WHEN THE PATIENT GOT UP QUICKLY, WAS SITTING DOWN ON A CHAIR, OR WAS GETTING UP IN THE MIDDLE OF THE NIGHT ¿IT COMES IMMEDIATELY¿ WHICH STARTED A COUPLE OF MONTHS AGO. IT WAS UNCLEAR WHAT ¿IT COMES IMMEDIATELY¿ REFERRED TO. IT WAS REPORTED THAT PROGRAM 2 WAS AT 3.9 VOLTS, PROGRAM 3 WAS AT 5.9 VOLTS, PROGRAM 4 WAS AT 5.3 VOLTS, AND THE PATIENT WAS NOT FEELING STIMULATION ON ANY SETTING. IT WAS NOTED THAT THE PATIENT WENT BACK TO PROGRAM 2 AT 3.9 VOLTS. THE REPORTER STATED THAT THE PATIENT HAD A DIFFICULT TIME USING THE ANTENNA AND PATIENT PROGRAMMER TO COMMUNICATE. IT WAS NOTED THAT THERE WAS A PROBLEM WITH THE PATIENT PROGRAMMER AND THE PATIENT WAS NOT ABLE TO MAKE ADJUSTMENTS WITH THE ANTENNA ATTACHED. IT WAS LATER REPORTED THAT THE PATIENT PROGRAMMER WOULD NOT WORK WITH THE EXTERNAL ANTENNA. ANALYSIS OF THE PATIENT PROGRAMMER REVEALED NO ANOMALY. 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
    70788 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00090 YR