BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FISHER WALLACE CRANIEL NEUROSTIMULATOR

    MDR report key: 16862266 · Received May 3, 2023

    Report

    Report Number
    3006258094-2023-00002
    Event Type
    Injury
    Date Received
    May 3, 2023
    Date of Event
    February 5, 2023
    Report Date
    January 26, 2023
    Manufacturer
    FISHER WALLACE LABS
    Product Code
    QJQ
    PMA / PMN Number
    K903654
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    NONSPECIFIC T WAVE ABNORMALITY. I DEVELOPED BRADYCARDIA AFTER TWO SESSION OF USE. I PERFORMED AN ECG IN (B)(6) 2022 NORMAL WITH PHYSICAL. I MY FISHER WALLACE STIMULATOR ON THE (B)(6) 2023, I HAD SCREENING PHYSICAL ON (B)(6) 2021 AND MY ECG SHOWED A NONSPECIFIC T WAVE ABNORMALITY OR SINUS BRADYCARDIA. SINCE MY PREVIOUS TEST WERE NORMAL PRIOR TO USE OF THE STIMULATOR, AND AFTER US MY ECG IS ABNORMAL I THINK THIS IS TO CLOSE TO BE A COINCIDENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    811265 FISHER WALLACE CRANIEL NEUROSTIMULATOR CRANIEL NEUROSTIMULATOR QJQ FISHER WALLACE LABS FW-100

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other