BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2182207-2020-01123

    MDR report key: 10717624 · Received October 22, 2020

    Report

    Report Number
    2182207-2020-01123
    Event Type
    Injury
    Date Received
    October 22, 2020
    Date of Event
    October 2, 2020
    Report Date
    October 22, 2020
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A TRIAL PATIENT WHO WAS USING AN EXTERNAL NEUROSTIMULATOR (ENS) FOR URGE INCONTINENCE; THE TRIAL STARTED (B)(6) 2020. IT WAS REPORTED THAT THE PATIENT MENTIONED PAIN IN THEIR BUTTOCKS ON THE RIGHT SIDE WHEN STIMULATION WAS MENTIONED. THEY SWITCHED SIDES AND IT WAS COMFORTABLE. THEY STATED THEY WERE IN THE HOSPITAL DUE TO A RASH CAUSED BY THE TAPE PROVIDED FROM THE PROCEDURE. THEY WERE ADVISED TO CONTACT THEIR CLINICIAN. CONTRIBUTING FACTORS WERE UNKNOWN, THE ISSUE WAS NOT RESOLVED AT THE TIME OF THE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1183586 EZW MEDTRONIC NEUROMODULATION NEU_ADHESIVE_ACC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization