BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 6038155 · Received October 18, 2016

    Report

    Report Number
    3004209178-2016-22020
    Event Type
    Malfunction
    Date Received
    October 18, 2016
    Date of Event
    September 22, 2016
    Report Date
    December 5, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE IPG 3058 INTERSTIM LL, (B)(4), FOUND THAT THE INS SET SCREW WAS BACKED OUT TOO FAR.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE MANUFACTURER REPRESENTATIVE (REP) REPORTED THAT DURING IMPLANT ON DATE NOTIFIED AN IMPEDANCE TEST WAS RUN AT 2.0V AND 360 PW, WITH SOME CONTACTS SHOWING AS HIGH AND > 4000 OHMS. THERE WAS NO TROUBLE INSERTING THE LEAD, AND THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS BEING USED TO TEST FOR MOTOR RESPONSE. THE RATE WAS NOTED TO BE AT 14 AND PW AT 210 US, WITH CYCLIC SET AT 3S ON/3S OFF. AMPLITUDE WAS THEN INCREASED WITH THE CLINICIAN PROGRAMMER AND BELLOWS AND TOE FLICK WERE PRESENT AT NOMINAL AMPLITUDE VALUES, WITH IT BEING INDICATED THAT THE MOTOR RESPONSE IS MORE NOTICEABLE DURING IMPEDANCE CHECK. THERE WERE NO PATIENT SYMPTOMS ALLEGED. INDICATION FOR IMPLANT IS URINARY DYSFUNCTION/SACRAL NERVE STIMULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    688476 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR