BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3584919 · Received January 21, 2014

    Report

    Report Number
    3004209178-2014-00853
    Event Type
    Injury
    Date Received
    January 21, 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
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3093-28, LOT# V075268, IMPLANTED: (B)(6) 2008-02-05 PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008-02-05 PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3037, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008-02-05 PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT PROGRAMMER WAS NOT WORKING AND ON (B)(6) 2013, NOTHING WAS COMING UP ON THE PATIENT PROGRAMMER SCREEN. IT WAS NOTED THAT THE PATIENT REPLACED THE BATTERIES THE NEXT DAY AND NOTHING WOULD COME ON THE SCREEN. THE REPORTER STATED THAT THE PATIENT REPLACED THE BATTERIES AT THE TIME OF THE REPORT AND THE PATIENT PROGRAMMER STARTED TO WORK. IT WAS REPORTED THAT THE PATIENT SAW A MESSAGE TELLING HER THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS GETTING LOW AND THERE WAS AN ELECTIVE REPLACEMENT INDICATOR (ERI) MESSAGE. IT WAS NOTED THAT THE DAY OF THE REPORT WAS THE FIRST TIME THE PATIENT SAW THE INS BATTERY LOW MESSAGE. IT WAS REPORTED THAT THE PATIENT USUALLY CHECKED THE INS ONCE A MONTH, BUT BECAUSE THE PATIENT HAD BEEN BUSY SHE HADN¿T CHECKED IT IN ABOUT SIX WEEKS. IT WAS LATER REPORTED THE DEVICE WAS EXPLANTED. IT WAS NOTED THE PATIENT HAD STIMULATION IN THE WRONG LOCATION. REPORTEDLY, AFTER BEING IMPLANTED ALMOST 5 YEARS THE PATIENT BEGAN TO FEEL STIMULATION DIFFERENTLY IN THE VAGINAL AREA ABOUT 6 MONTHS PRIOR TO REPORT. IT WAS STATED THE PATIENT DIDN¿T FEEL LIKE THE STIMULATION WAS WORKING AS WELL. IT WAS NOTED THE BATTERY WAS MEASURING BETWEEN 0-1 MONTHS LEFT. IT WAS NOTED THE PATIENT EXPERIENCED A BURNING SENSATION AND PAIN ON ONE SIDE OF THEIR VAGINA. THE PATIENT¿S STATUS WAS REPORTED AS NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50329 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR Required Intervention