BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 8302862 · Received February 4, 2019

    Report

    Report Number
    3004209178-2019-02395
    Event Type
    Injury
    Date Received
    February 4, 2019
    Date of Event
    December 1, 2018
    Report Date
    February 4, 2019
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    UDI-DI
    00613994913654
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIMULATION AND GASTROINTESTINAL/PELVIC FLOOR ISSUES. IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HCP¿S OFFICE FOR THE EVALUATION OF PROGRESSIVE URINARY URGENCY. IT WAS NOTED THAT THE PATIENT WAS SEEN EARLIER THAT YEAR, AT WHICH TIME THEIR BATTERY LIFE WAS 0-13% AND 0 MONTHS. AT THE TIME OF THE VISIT, THE PATIENT FELT THEIR URINARY URGENCY HAD PROGRESSED IN SEVERITY, ALTHOUGH THEY STILL FELT SOME STIMULATION FROM THE DEVICE. THE PREOPERATIVE DIAGNOSIS WAS THAT THE PATIENT HAD AN IMPLANT THAT WAS NOT WORKING ANYMORE AND IT WAS GOING TO BE REMOVED AND REPLACED. DURING THE PROCEDURE, EACH ELECTRODE WAS TESTED FOR LOCATION OF THE PATIENT¿S SENSATION, VISUALIZATION OF BELLOWS AND PLANTER FLEXION OF THE GREAT TOE. THE PROGRAMMING HEAD WAS PLACED OVER THE IMPLANTED NEUROSTIMULATOR IN A STERILE COVER TO ENSURE ADEQUATE LEAD CONNECTION AND THAT THE PARAMETERS WERE WITHIN NORMAL LIMITS; IMPEDANCES WERE CONFIRMED TO BE WITHIN NORMAL LIMITS, GREATER THAN 50 AND LESS THAN 4,000. IT WAS NOTED THAT THE PATIENT TOLERATED THE PROCEDURE WELL, BLOOD LOSS WAS MINIMUM, AND THE PATIENT WAS TRANSFERRED TO RECOVERY IN STABLE CONDITION AND WOULD BE SEEN IN THE OFFICE IN 1-2 WEEKS. IT WAS NOTED THAT NO BATTERY LIFE WAS DETECTED ON THE BATTERY CHECK. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96036 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058 00613994913654

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention