BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 6281170 · Received January 26, 2017

    Report

    Report Number
    3004209178-2017-01829
    Event Type
    Injury
    Date Received
    January 26, 2017
    Date of Event
    December 1, 2016
    Report Date
    March 13, 2017
    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
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 3093-33, LOT# V871805, PRODUCT TYPE: LEAD.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER (CON) REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR. IT WAS REPORTED THAT THE PATIENT'S IMPLANT DIDN'T SEEM TO BE WORKING RIGHT. THEY DID NOT HAVE MUCH CONTROL AT ALL OVER THEIR BLADDER, SINCE (B)(6) 2016, AND THEY HAD ALREADY INCREASED THE STIMULATION. IT WAS NOTED THAT THEY CHANGED PROGRAMS TWO OR THREE YEARS AGO AND IT HELPED A LOT. IT WAS FOUND THAT THE THERAPY WAS NOT ON. A FALL WAS REPORTED TO HAVE HAPPENED IN (B)(6) 2017, WHICH COULD HAVE BEEN RELATED TO THE ISSUE. THEY INCREASED THE STIMULATION FROM 1.8 V TO 1.9 V ON THE DAY PRIOR TO THE REPORT AND IT WAS STILL NOT HELPING. THEY DIDN'T HAVE ACCESS TO ADDITIONAL PROGRAMS. THEY WERE GOING TO INCREASE THE STIMULATION SOME MORE AND, IF THAT DOESN'T HELP, THEY WOULD CONTACT A HEALTHCARE PROFESSIONAL (HCP).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT. IT WAS REPORTED THAT THE PATIENT MET WITH THEIR DOCTOR ON (B)(6) 2017. THE PATIENT REPORTED THAT THEY HAD A TEST AND THAT IT FOUND A UTI AND THAT THEY WERE GIVEN ANTIBIOTICS TO TREAT IT. THE PATIENT WAS WAITING FOR AN APPOINTMENT TO REPLACE THE IMPLANT. THE PATIENT REPORTED THAT THE BATTERY WAS LOW AND THAT THE FALL IN (B)(6) CAUSED ONE OF THE LEADS TO COME LOOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63996 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention