BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3922796 · Received July 9, 2014

    Report

    Report Number
    3004209178-2014-12725
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Report Date
    June 16, 2014
    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
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID 3889-28, LOT # VA0EEC2, IMPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING A LOSS OF THERAPEUTIC EFFECT. THE PATIENT NOTICED INCREASE IN FREQUENCY ABOUT 2 DAYS AGO. YESTERDAY, THE PATIENT DID CONTACT AND SPEAK WITH MANUFACTURER'S REPRESENTATIVE ABOUT THIS. THE PATIENT HAD BEEN DOING PHYSICAL THERAPY EXERCISES AND ALSO NOTED THAT SHE DID HAVE ONE TREATMENT OF THERAPEUTIC ULTRASOUND. THE PATIENT WAS NOT AWARE SHE COULDN'T HAVE. AT THIS POINT, PATIENT HAD NOT INFORMED PHYSICAL THERAPIST THAT SHE HAS AN IMPLANTED DEVICE. THE PATIENT ALSO MENTIONED THAT SHE DID HAVE A FALL ABOUT 6 WEEKS AGO AND FELL ON HER RIGHT SIDE, WHICH IS THE OPPOSITE SIDE HER IMPLANT WAS PLACED. THE PATIENT DID CHECK HER DEVICE AND INCREASED THE STIMULATION AND WONDERING IF THAT WAS THE RIGHT THING TO DO. THE FOLLOWING SERVICE OR EDUCATION ISSUE(S) WERE OBSERVED BY PATS AGENT: PATIENT LACKED BASIC UNDERSTANDING OF: THE THERAPY. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400476 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR