BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 11436142 · Received March 8, 2021

    Report

    Report Number
    3004209178-2021-03846
    Event Type
    Malfunction
    Date Received
    March 8, 2021
    Date of Event
    March 3, 2021
    Report Date
    March 8, 2021
    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
    LA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3889-33, LOT#: VA12FHQ, IMPLANTED: (B)(6) 2016, PRODUCT TYPE: LEAD. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 3889-33, SERIAL/LOT #: (B)(4), UBD: 09-DEC-2019, 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 PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIM AND GASTROINTESTINAL/ PELVIC FLOOR. IT WAS REPORTED THAT THE PATIENT CALLED TO SEE IF THEY COULD HAVE AN MRI OF THEIR SHOULDER. REVIEWED PUTTING THE DEVICE IN MRI MODE. WHEN THE PATIENT PUT THE DEVICE IN MRI MODE, THEY SAW A MESSAGE THAT ELIGIBILITY COULDN'T BE DETERMINED. THEY SAID THE SCREEN SAID NOT ELIGIBLE DUE TO ABANDONED COMPONENT WITH THE CODE 0131310. THEY NOTED THE REASON THEY HAD THE DEVICE REPLACED WAS SO THEY COULD HAVE THE SHOULDER MRI. THEY WERE SUPPOSED TO REMOVE EVERYTHING. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336786 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058 00613994913654

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR