BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 4974854 · Received August 5, 2015

    Report

    Report Number
    3004209178-2015-15440
    Event Type
    Malfunction
    Date Received
    August 5, 2015
    Report Date
    July 13, 2015
    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
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3037, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3889-28, LOT # V192542, IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    (B)(4). THE CONSUMER REPORTED THE IMPLANTABLE NEUROSTIMULATOR (INS) "MOVED" AND SAT UP" AFTER CHEMOTHERAPY CAUSED THE PATIENT TO LOSE WEIGHT IN (B)(6) 2014. IN (B)(6) 2014, THE DEVICE "NEEDED REPLACING," BUT THE SETTINGS WERE LOW AND THE PATIENT WAS GOING THROUGH CHEMOTHERAPY. ON (B)(6) 2015, THERE WAS A SUDDEN LOSS OR CHANGE IN THERAPY AND SYMPTOMS; THE PATIENT LOST ALL CONTROL OF HER BLADDER AND WAS GOING THROUGH DEPENDS "LIKE CRAZY." NO PROGRAMMER WAS IN POSSESSION TO CHECK THE DEVICE OR TURN UP SETTINGS. PATIENT HISTORY INCLUDED DIABETES, BREAST CANCER, AND TAKING LONGER TO HEAL AFTER SURGERIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518516 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1