BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REACTIV8

    MDR report key: 19641432 · Received July 1, 2024

    Report

    Report Number
    3013017877-2024-00048
    Event Type
    Injury
    Date Received
    July 1, 2024
    Date of Event
    June 3, 2024
    Report Date
    June 30, 2024
    Manufacturer
    MAINSTAY MEDICAL LIMITED
    Product Code
    QLK
    UDI-DI
    05391527770015
    PMA / PMN Number
    P190021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MML REFERENCE (B)(4) B2-OTHER: PROTRUDING/PAIN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT COMPLAINED OF PAIN AT THE IMPLANTABLE PULSE GENERATOR (IPG) POCKET SITE. THE IPG MIGRATED AND PROTRUDED FROM THE TOP. THE PHYSICIAN PERFORMED A SURGICAL PROCEDURE TO REPOSITION THE IPG, AND THE PATIENT REPORTED FEELING BETTER AFTER SURGERY. FOLLOWING THE IPG REPOSITIONING, THE REACTIV8 SYSTEM WAS ACTIVATED TO ALLOW THE PATIENT TO INITIATE BILATERAL STIMULATION. THE DEVICE MANUFACTURING RECORD WAS REVIEWED, AND NO RELEVANT NONCONFORMANCES WERE FOUND. THE DEVICE REMAINS IMPLANTED AND FUNCTIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    785035 REACTIV8 REACTIV8 IMPLANTABLE PULSE GENERATOR QLK MAINSTAY MEDICAL LIMITED 5100 05391527770015

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other