BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3421997 · Received October 22, 2013

    Report

    Report Number
    3004209178-2013-19451
    Event Type
    Malfunction
    Date Received
    October 22, 2013
    Report Date
    October 1, 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
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 3889-28, LOT# V850492, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE THE PATIENT WAS SEEN IN THE FIRST PART OF (B)(6) 2013 DUE TO HAVING TO PEE WHEN AROUND RUNNING WATER. IT WAS STATED THAT WHEN THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS CHECKED ALL THE PROGRAM INFORMATION WAS GONE. THE PATIENT WAS TOLD IT WAS DUE TO THE BATTERY GOING BAD AND HAD TO CHANGE BATTERIES. THIS WAS THE SECOND TIME IN 1.5 YEARS THAT THE PATIENT HAD TO CHANGE BATTERIES IN THE PROGRAMMER. THE PATIENT DENIED GOING THROUGH SECURITY GATES, HAVING MRI, OR A CT SCAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542520 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00042 YR