BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERIFY ENHANCED

    MDR report key: 12681247 · Received October 22, 2021

    Report

    Report Number
    2182207-2021-01849
    Event Type
    Injury
    Date Received
    October 22, 2021
    Date of Event
    September 23, 2021
    Report Date
    October 22, 2021
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: DATE IS ESTIMATED; MONTH AND YEAR ARE VALID. 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) 2021. IT WAS REPORTED THAT THE PATIENT WAS WORN OUT AND NOT FEELING WELL, SO THEY PICKED UP SOME ANTIBIOTICS AND PAIN MEDICATION. THE BREATHING TUBE DURING THE PROCEDURE FOR THE ANESTHESIA HAD CAUSED THEIR THROAT TO BECOME SWOLLEN AND SORE (NO ALLEGATION RELATED TO DEVICE/THERAPY). THEY ALSO STATED IT BUSTED THEIR LIP OPEN AND THEY WERE HAVING CHEST PAIN (NO ALLEGATION RELATED TO DEVICE/THERAPY). THEY WERE LYING IN BED AND HARDLY HAVING ANYTHING TO EAT OR DRINK SINCE THE PROCEDURE. THEY WERE ADVISED TO CONTACT THEIR CLINICIAN REGARDING MEDICAL ADVICE OR IF THEY HAD QUESTIONS ABOUT THEIR HEALTH. NO DIAGNOSTICS/TROUBLESHOOTING WAS PERFORMED, AND NO INTERVENTIONS/ACTIONS WERE TAKEN. THE ISSUE WAS NOT RESOLVED AT THE TIME OF THE REPORT. THERE WERE NO DEVICE ISSUES NOR FURTHER PATIENT COMPLICATIONS REPORTED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1576414 VERIFY ENHANCED STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON EZW MEDTRONIC NEUROMODULATION 353101

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention