BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUNSTIM PERIPHERAL NERVE STIMULATOR/SUNSTIM PLUS PERIPHERAL NERVE STIMULATOR

    MDR report key: 20246279 · Received September 17, 2024

    Report

    Report Number
    MW5159676
    Event Type
    Malfunction
    Date Received
    September 17, 2024
    Report Date
    September 17, 2024
    Manufacturer
    EASYMED INSTRUMENTATION CO., LTD.
    Product Code
    BXN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    CALLER STATES HE HAS THREE MODEL 8-1053-60 DEVICES THAT HAVE ISSUES. ONE IS NOT WORKING, TWO OF THEM HAVE A HOLE IN THEM NEAR BUTTONS/'TWITCH'. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2). REFERENCE REPORTS: MW5159677, MW5159678.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2527908 SUNSTIM PERIPHERAL NERVE STIMULATOR/SUNSTIM PLUS PERIPHERAL NERVE STIMULATOR STIMULATOR, NERVE, BATTERY-POWERED BXN EASYMED INSTRUMENTATION CO., LTD. 8-1053-60

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown