BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3283199 · Received August 12, 2013

    Report

    Report Number
    3004209178-2013-14487
    Event Type
    Malfunction
    Date Received
    August 12, 2013
    Report Date
    July 18, 2013
    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
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3037, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID: 3093-28, LOT# V120752, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD; PRODUCT ID: 3037, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STIMULATION WAS IN THE WRONG LOCATION. IT WAS NOTED THAT THERE WAS NO KNOWN ACCIDENT OR INCIDENT RELATED TO THIS COMPLAINT. IT WAS NOTED THAT THE PATIENT SAW THE HEALTH CARE PROFESSIONAL (HCP) SIX DAYS PRIOR TO THIS REPORT AND IT WORKED WELL. IT WAS NOTED THAT FOUR OR FIVE DAYS PRIOR TO REPORTING THE STIMULATION MOVED. IT WAS NOTED THAT THE PATIENT'S SYMPTOMS WERE IN THE PERINEUM. IT WAS NOTED THAT THE PATIENT COULD NOT SEEM "TO GET THE FLUTTER PART RIGHT." IT WAS NOTED THAT THE PATIENT STATED THAT THE FLUTTER SHOULD BE AROUND HER VAGINAL AREA AND WAS THERE WHEN THE PATIENT WAS AT THE DOCTOR'S OFFICE SIX DAYS AGO. IT WAS NOTED THAT FIVE OR FOUR DAYS PRIOR TO THIS REPORT "THE FLUTTER THE PATIENT FELT, WHEN HER IMPLANT WAS ON THE RIGHT SIDE, BUT THE FLUTTER THE PATIENT FELT WAS IN THE BOTTOM OF THE PATIENT'S LEFT FOOT." IT WAS NOTED THAT THE PATIENT WAS ON PROGRAM 1 AT 1.3 VOLTS. IT WAS NOTED THAT STIMULATION WAS ON AND THE BOLT WAS SEEN. IT WAS NOTED THAT THE PATIENT BELIEVED THAT THE AMPLITUDE HAD ALWAYS BEEN AROUND 1.3 OR 1.1. IT WAS NOTED THAT WHEN THE PATIENT PRESSED THE NAVIGATOR KEY THE PATIENT FELT SOMETHING IN THE VAGINAL AREA. IT WAS NOTED WHILE CHANGING PROGRAMS THE PATIENT ACCIDENTLY ENDED UP ON PROGRAM 4 AT 1.2. IT WAS NOTED THAT IT WAS UNCOMFORTABLE AND THE PATIENT NEEDED TO DECREASE THE AMPLITUDE. IT WAS NOTED THAT THE PATIENT PRESSED THE DECREASE KEY AND "EVERY TIME THE PATIENT PRESSED THE MINUS THE PATIENT GOT SOMETHING DIFFERENT." IT WAS NOTED THAT THE PATIENT THOUGHT THAT THE PATIENT PROGRAMMER BATTERIES NEEDED TO BE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385401 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00049 YR