BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 7909657 · Received September 26, 2018

    Report

    Report Number
    3004209178-2018-21540
    Event Type
    Malfunction
    Date Received
    September 26, 2018
    Report Date
    September 26, 2018
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    UDI-DI
    00613994913654
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3093-28, LOT# V183293, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 3093-28, SERIAL/LOT #: (B)(4), UBD: 01-DEC-2012, UDI#: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIMULATION AND GASTROINTESTINAL/PELVIC FLOOR WHO REPORTED THAT THE PATIENT'S INS AND LEADS WERE REPLACED THE FRIDAY PRIOR TO THE CALL (B)(6) 2018. WHILE THE PATIENT REPORTED HAVING MULTIPLE LEADS THERE APPEARED TO HAVE ONLY BEEN A SINGLE LEAD IMPLANTED AND THE REPORT OF MULTIPLE LEADS APPEARED TO REFER TO ELECTRODES ON THE LEAD. THE PATIENT CONFIRMED THAT THE INS WAS REPLACED DUE TO NORMAL BATTERY DEPLETION AND THE LEAD WAS REPLACED BECAUSE "SOME LEADS WENT DEAD" AND THE PHYSICIAN ASSISTANT SAID SOME MOISTURE MAY HAVE GOTTEN IN. THE PATIENT REPORTED THAT "LEAD ONE" WAS ALREADY DEAD A LONG TIME AGO AND "THE OTHER 2 WENT DEAD 2-3 MONTHS AGO." THE IMPLANTED SYSTEM WAS REPLACED AND NO PATIENT SYMPTOMS WERE REPORTED. NO COMPLICATIONS WERE REPORTED OR ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    753097 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058 00613994913654

    Patients

    Seq Age Sex Outcome Treatment
    1