BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERIFY ENHANCED

    MDR report key: 11179552 · Received January 15, 2021

    Report

    Report Number
    2182207-2021-00080
    Event Type
    Injury
    Date Received
    January 15, 2021
    Date of Event
    December 17, 2020
    Report Date
    January 15, 2021
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: NEU_UNKNOWN_LEAD, LOT#: UNKNOWN, IMPLANTED: (B)(6) 2020, PRODUCT TYPE: LEAD. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL/LOT #: UNKNOWN. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM AN ADVANCED EVALUATION TRIAL PATIENT WHO WAS USING AN EXTERNAL NEUROSTIMULATOR (ENS) FOR URGE INCONTINENCE AND URGENCY FREQUENCY. THE TRIAL BEGAN (B)(6) 2020. IT WAS REPORTED THE TRIAL PATIENT HAD A BREATHING TUBE DURING THE PROCEDURE WHICH LEFT THEM WITH A SORE THROAT. NO DIAGNOSTICS/TROUBLESHOOTING WAS PERFORMED AND NO INTERVENTIONS/ACTIONS WERE TAKEN. THE ISSUE WAS NOT RESOLVED AT THE TIME OF THE REPORT. THEY WERE ADVISED TO CONTACT THEIR CLINICIAN WITH QUESTIONS REGARDING MEDICAL ADVICE OR IF THEY HAD QUESTIONS ABOUT THEIR HEALTH. ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT. THEY REPORTED THAT THEY HAD TO GO BACK IN TO HAVE THEIR LEADS REPLACED AND NOW THAT THE LEADS HAD BEEN REPLACED, THE THERAPY WAS GOING BETTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75577 VERIFY ENHANCED STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION 353101

    Patients

    Seq Age Sex Outcome Treatment
    1