BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2846631 · Received November 27, 2012

    Report

    Report Number
    3004209178-2012-10794
    Event Type
    Malfunction
    Date Received
    November 27, 2012
    Report Date
    October 31, 2012
    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
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3093-33, LOT# V941222, IMPLANTED: (B)(6) 2012. 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 THERE WAS A LOSS OF THERAPEUTIC EFFECT AND A POWER ON RESET (POR) CONDITION. IT WAS STATED THAT THE DEVICE HAD BEEN WORKING "FINE UP UNTIL A WEEK AND A HALF AGO." THE PATIENT REPORTEDLY HAD THE "URGENCY TO GO," HAD ISSUES WITH INCONTINENCE "AGAIN," AND COULD NOT FEEL THE "VIBRATION SHE WAS SUPPOSED TO GET FROM THE METER." IT WAS NOTED THAT THE PATIENT FORGOT HOW TO USE THE PATIENT PROGRAMMER. IT WAS STATED THAT THE PATIENT WAS UNABLE TO ADJUST STIMULATION AND SAW THE "CALL YOUR DOCTOR" ICON. IT WAS NOTED THAT THE PATIENT HAD CARDIOVERSION ON (B)(6) 2012 AND HAD NOT BEEN ABLE TO USE HER DEVICE SINCE. ADDITIONAL INFORMATION WAS REQUESTED AND IF RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD THE POR CLEARED AT AN APPOINTMENT ON EITHER (B)(6). IT WAS NOTED THAT THE PATIENT WAS VERY PLEASED WITH THE INTERSTIM, AND IT HAD WORKED WELL, HOWEVER SHE WAS GETTING A PACEMAKER IMPLANTED IN (B)(6) AND WAS CONCERNED THAT THE INTERSTIM WOULD STOP AGAIN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1