BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 5458124 · Received February 24, 2016

    Report

    Report Number
    3004209178-2016-03415
    Event Type
    Injury
    Date Received
    February 24, 2016
    Report Date
    February 2, 2016
    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
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3093-28, LOT# V955729, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    THE CONSUMER REPORTED THAT THERE WAS A POWER-ON-RESET (POR) ERROR CODE. ALSO, THE PATIENT STOPPED FEELING STIMULATION. THE HEALTH CARE PROFESSIONAL (HCP) DETERMINED 3 WEEKS PRIOR TO (B)(6) 2015 THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) BATTERY WAS LOW. THEY SCHEDULED FOR THE INS REPLACEMENT IN (B)(6) OF 2015. AT THE APPOINTMENT 3 WEEKS PRIOR, THE HCP DETERMINED "THE LEAD WAS NOT MAKING THE RIGHT CONNECTION OR SOMETHING OR WAS NOT READING SOMETHING." THEY COULD NOT BRING IT UP ON THE PROGRAMMER. THERE WERE NO ELECTROMAGNETIC INTERFERENCE (EMI) RELATED TO THE ISSUE. THE INDICATION-FOR-USE (IFU) WAS URINARY DYSFUNCTION/SACRAL NERVE STIM AND GASTROINTESTINAL/PELVIC FLOOR. ADDITIONAL INFORMATION RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT THE PATIENT EXPERIENCED WORSENING INCONTINENCE. REPROGRAMMING WAS PERFORMED. THE ISSUES WERE NOT RESOLVED AND A SURGERY WAS REQUIRED DUE TO LACK OF EFFICACY. IT WAS NOTED THAT THE CAUSE OF THE ISSUES WAS DETERMINED TO BE BECAUSE THE INTERSTIM THERAPY AND NERVE WAS NO LONGER EFFECTIVE AT THE PRESENT NERVE SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114974 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention