BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 5434063 · Received February 12, 2016

    Report

    Report Number
    3004209178-2016-02740
    Event Type
    Malfunction
    Date Received
    February 12, 2016
    Report Date
    January 20, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CONSUMER REPORTED THAT THE PATIENT WAS HAVING AN ISSUE WITH THEIR HEART 1 WEEK AGO. THE PATIENT HAD IRREGULAR HEART BEAT AND CHEST PAIN DURING A PHYSICAL THERAPY WORKOUT. THIS WAS DUE TO A SUDDEN CHANGE IN THERAPY OR SYMPTOMS. THE PATIENT THOUGHT THE IRREGULAR HEART BEAT AND CHEST PAIN COULD BE RELATED TO THE PATIENT'S DEVICE OR THERAPY. THE PATIENT WAS NOT HAVING THIS PROBLEM UNTIL THEY HAD THE DEVICE. THE PATIENT HAD NOTIFIED AN ER DOCTOR AND NURSE AND THEIR GENERIC DOCTOR ABOUT THEIR IRREGULAR HEART BEAT AND CHEST PAIN. THE STEPS TAKEN TO RESOLVE THE IRREGULAR HEART BEAT AND CHEST PAIN WERE THAT THE PATIENT WAS SEEING THEIR INTERNAL MEDICINE DOCTOR AND THEY CHANGED SOME MEDICATIONS AROUND. THE PATIENT WAS STILL HAVING THIS PROBLEM. THE INDICATIONS FOR USE FOR THIS PATIENT WERE URINARY DYSFUNCTION/SACRAL NERVE STIMULATION AND GASTROINTESTINAL/PELVIC FLOOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91813 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058

    Patients

    Seq Age Sex Outcome Treatment
    1