BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REACTIV8

    MDR report key: 23421685 · Received October 30, 2025

    Report

    Report Number
    3021520203-2025-00102
    Event Type
    Malfunction
    Date Received
    October 30, 2025
    Date of Event
    September 30, 2025
    Report Date
    January 21, 2026
    Manufacturer
    MAINSTAY MEDICAL LIMITED
    Product Code
    QLK
    PMA / PMN Number
    P190021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MML# (B)(4). THE PATIENT WAS A CLINICAL STUDY PARTICIPANT WITH AN OLD LEAD DESIGN. OTHER LEAD EXPLANTED. MODEL: 800045. DESCRIPTION: REACTIV8 STIMULATION LEAD. SERIAL NUMBER: (B)(6). UDI: UNKNOWN. FOLLOWING THE LEAD REVISION, THE REACTIV8 SYSTEM WAS ACTIVATED TO ALLOW THE PATIENT TO INITIATE BILATERAL STIMULATION (WHEN INITIATED BY THE PATIENT). THE LEAD ASSEMBLIES WERE RECEIVED FOR ANALYSIS. BOTH LEADS FAILED THE FUNCTIONAL TESTING. THE OUT-OF-RANGE/HIGH IMPEDANCE FAILURE WAS CONFIRMED. VISUAL INSPECTION OBSERVED ROUNDED, FRACTURED COIL WIRES. SECTION B5 AND H6 WERE UPDATED.

    Additional Manufacturer Narrative · 0

    MML# (B)(4). THE PATIENT WAS A CLINICAL STUDY PARTICIPANT WITH AN OLD LEAD DESIGN. OTHER LEAD EXPLANTED MODEL: 800045, DESCRIPTION: REACTIV8 STIMULATION LEAD, SERIAL NUMBER: (B)(6), UDI: UNKNOWN.

    Description of Event or Problem · 0

    DURING THE ROUTINE PATIENT VISIT, THE RIGHT LEAD WAS FOUND TO HAVE AN OUT-OF-RANGE/HIGH-IMPEDANCE ISSUE. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THE DEVICE WAS REPROGRAMMED TO ANOTHER WORKING ELECTRODE, AND THE PATIENT CONTINUED BILATERAL STIMULATION WHILE AWAITING SCHEDULING OF THE REVISION. THE PATIENT UNDERWENT REVISION SURGERY TO REPLACE THE RIGHT LEAD, AND THE LEFT LEAD WAS REPLACED AS A PRECAUTION. THE LEADS WERE AN OLD DESIGN AND WERE INCOMPATIBLE WITH MRI. THE LEADS WERE REMOVED COMPLETELY, AND TWO NEW LEADS WERE IMPLANTED WITHOUT COMPLICATIONS.

    Description of Event or Problem · 0

    DURING THE ROUTINE PATIENT VISIT, THE RIGHT LEAD WAS REPORTED TO HAVE AN OUT-OF-RANGE/HIGH IMPEDANCE ISSUE. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THE DEVICE WAS REPROGRAMMED TO ANOTHER WORKING ELECTRODE, AND THE PATIENT CONTINUED BILATERAL STIMULATION AFTERWARD WHILE WAITING FOR THE REVISION TO BE SCHEDULED. THE PATIENT UNDERWENT REVISION SURGERY TO REPLACE THE RIGHT LEAD, AND THE LEFT LEAD WAS REPLACED AS A PRECAUTION. THE LEADS WERE AN OLD DESIGN AND WERE INCOMPATIBLE WITH MRI. THE LEADS WERE REMOVED COMPLETELY, AND TWO NEW LEADS WERE IMPLANTED WITHOUT COMPLICATIONS. THE REMOVED LEADS WERE NOT RETURNED FOR ANALYSIS, SO PRODUCT ANALYSIS CAN BE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1541189 REACTIV8 REACTIV8 IMPLANTABLE STIMULATION LEAD QLK MAINSTAY MEDICAL LIMITED 800045

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male