BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 4151229 · Received October 8, 2014

    Report

    Report Number
    3004209178-2014-18480
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Report Date
    October 3, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3889-28, LOT # VA09VSA, IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT NEVER HAD THERAPEUTIC EFFECT. THE PATIENT NOTICED NO DIFFERENCE IN SYMPTOMS IF THERAPY WAS ON OR OFF. OCCASIONALLY, THE PATIENT EXPERIENCED A SHOCKING SENSATION IN THEIR RIGHT LABIA. REPROGRAMMING WOULD RESULT IN COMFORTABLE STIMULATION, BUT WOULD GET PAINFUL ON THE DRIVE HOME, ESPECIALLY WITH POSITIONAL CHANGES. THE LAST REPROGRAMMING SESSION RESULTED IN STIMULATION CLOSER TO THE RECTUM. THE STIMULATION BEGAN TO IRRITATE THE PATIENT AND CAUSE RECTAL PAIN. THE PATIENT¿S HEMORRHOIDS WERE GETTING BIGGER. THE PATIENT HAD TO TURN STIMULATION OFF, AS THEY COULD NOT SLEEP WITH THE PAIN. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632471 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR