BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3872018 · Received June 13, 2014

    Report

    Report Number
    3004209178-2014-11551
    Event Type
    Injury
    Date Received
    June 13, 2014
    Report Date
    May 23, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID NEU_UNKNOWN_LEAD, SERIAL # UNKNOWN, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL # (B)(6), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ALL THE PATIENT SAW ON THEIR PATIENT PROGRAMMER SCREEN WAS THE SPLASH SCREEN. THE PATIENT HAD NEVER CHANGED THE BATTERIES IN THE PROGRAMMER AND THEY WOULD GET NEW BATTERIES AND SEE IF THAT RESOLVED THE ISSUE. IT WAS NOTED THAT THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT. THE PATIENT HADN¿T USED THE PROGRAMMER BECAUSE THEY WERE GETTING GOOD THERAPY. IT WAS REPORTED THAT THE PATIENT HAD BEEN HAVING TROUBLE WITH THEIR BLADDER THE LAST COUPLE OF DAYS AND INITIALLY THOUGHT IT WAS A BLADDER INFECTION. THE PATIENT THEN REMEMBERED TO ADJUST THE IMPLANTABLE NEUROSTIMULATOR (INS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349043 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention