BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 9605065 · Received January 20, 2020

    Report

    Report Number
    3004209178-2020-01383
    Event Type
    Injury
    Date Received
    January 20, 2020
    Report Date
    January 19, 2020
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    UDI-DI
    00613994913654
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3889-28, LOT#: V072260, IMPLANTED: (B)(6) 2008, EXPLANTED: (B)(6) 2020, PRODUCT TYPE: LEAD. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 3889-28, SERIAL/LOT #: (B)(4), UBD: 10-DEC-2011, 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 VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR (INS) FOR GASTROINTESTINAL/PELVIC FLOOR AND URINARY DYSFUNCTION/SACRAL NERVE STIM. IT WAS REPORTED THAT THE PATIENT HAD A FALL AND SINCE THEN EFFICACY HAD NOT BEEN GOOD. THE PATIENT WAS ALSO ABLE TO INCREASE STIMULATION A LOT HIGHER THEN TYPICAL BEFORE FEELING ANY STIMULATION. THE PATIENT DENIED ANY X-RAY OR REPROGRAMMING AND IMPEDANCES CHECKED PRIOR TO REVISION WERE ALL NORMAL. THE LEAD WAS REMOVED INTACT, WITHOUT ISSUE, AND A NEW LEAD WAS IMPLANTED ON THE LEFT SIDE. THE ISSUE WAS NOTED TO BE RESOLVED AND NO FURTHER PATIENT COMPLICATIONS ARE ANTICIPATED OR EXPECTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    70739 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058 00613994913654

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention