BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REACTIV8

    MDR report key: 20312399 · Received September 26, 2024

    Report

    Report Number
    3013017877-2024-00072
    Event Type
    Injury
    Date Received
    September 26, 2024
    Date of Event
    August 28, 2024
    Report Date
    September 26, 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). OTHER DEVICE EXPLANTED. MODEL: 8145. DESCRIPTION: PERCUTANEOUS STIMULATION LEADS. SERIAL NUMBERS: (B)(6). UDI#:(B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT BENEFITED FROM THE THERAPY, AND THE DEVICE PERFORMED AS INTENDED. HOWEVER, THE IMPLANTABLE PULSE GENERATOR (IPG) WAS STICKING OUT AND CAUSING PAIN, SO THE PATIENT DECIDED TO HAVE THE DEVICE REMOVED. THE DEVICE WAS REMOVED WITHOUT ANY COMPLICATIONS. IT WAS REPORTED THAT THE DEVICE WAS DISCARDED AT THE HOSPITAL. THEREFORE, NO DEVICE ANALYSIS CAN BE PERFORMED. THE DEVICE HISTORY RECORD WAS REVIEWED. NO RELEVANT NONCONFORMANCES WERE FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2198716 REACTIV8 REACTIV8 IMPLANTABLE PULSE GENERATOR QLK MAINSTAY MEDICAL LIMITED 5100 05391527770015

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female Other