BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REACTIV8

    MDR report key: 19746851 · Received July 15, 2024

    Report

    Report Number
    3013017877-2024-00050
    Event Type
    Injury
    Date Received
    July 15, 2024
    Date of Event
    April 10, 2024
    Report Date
    July 15, 2024
    Manufacturer
    MAINSTAY MEDICAL LIMITED
    Product Code
    QLK
    UDI-DI
    05391527770015
    PMA / PMN Number
    P190021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MML REFERENCE #: (B)(4). THE DEVICE MANUFACTURE DATES ARE INCLUDED IN D4 - UDI NUMBER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2024, DUE TO THE PATIENT HAVING A TRANSIENT ISCHEMIC ATTACK (TIA) EPISODE APPROXIMATELY THREE WEEKS POST-INITIAL REACTIVE SYSTEM IMPLANT PROCEDURE. THE PATIENT WAS ADMITTED FOR ONGOING EVALUATION AND TREATMENT. REPORTEDLY, THE PATIENT HAD TO BE OFF THEIR MEDICATION TO HAVE THE IMPLANT PROCEDURE. THE TYPE OF MEDICATION AND DOSAGE ARE UNKNOWN. FURTHER INFORMATION WAS RECEIVED STATING THAT THE PATIENT HAD APHASIA. THE PATIENT STATES THAT HE HAS HAD ABOUT 3-4 EPISODES IN WHICH HE IS NOT ABLE TO GET HIS WORDS OUT AND EXPRESS HIMSELF. IT IS UNKNOWN IF THESE EPISODES WERE BEFORE OR AFTER THE IMPLANT PROCEDURE. THE PATIENT ALSO STATES HE HAD DYSARTHRIA AND SLIGHT DISORIENTATION. THE PATIENT REPORTED HAVING A HISTORY OF TIAS IN THE PAST AND CAME TO THE ER FOR EVALUATION. A COMPUTED TOMOGRAPHY (CT) SCAN AND BRAIN MAGNETIC RESONANCE IMAGING (MRI) WERE TAKEN. NO ACUTE FINDINGS WERE NOTED. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY. ACCORDING TO THE IMPLANTING PHYSICIAN, THE DEVICE HAS NO RELATIONSHIP WITH THE INCIDENT. THE DEVICE REMAINS IMPLANTED AND FUNCTIONAL. THE DEVICE MANUFACTURING RECORD WAS REVIEWED. NO RELEVANT NONCONFORMANCES WERE FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693903 REACTIV8 REACTIV8 SYSTEM QLK MAINSTAY MEDICAL LIMITED 5100 / 8145 4693 / D21120506 / D21120507 05391527770015

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Other