BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REACTIV8

    MDR report key: 23873706 · Received December 22, 2025

    Report

    Report Number
    3021520203-2025-00142
    Event Type
    Injury
    Date Received
    December 22, 2025
    Date of Event
    November 25, 2025
    Report Date
    February 25, 2026
    Manufacturer
    MAINSTAY MEDICAL LIMITED
    Product Code
    QLK
    UDI-DI
    05391527772002
    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). OTHER DEVICE REPLACED: MODEL: 8000-45. DESCRIPTION: REACTIV8 IMPLANTABLE STIMULATION LEAD. SERIAL NUMBER: (B)(6). THE LEAD ASSEMBLIES WERE RECEIVED FOR ANALYSIS. THE ALLEGED OUT-OF-RANGE (OOR) WAS NOT CONFIRMED. BOTH LEADS PASSED FUNCTIONAL TESTING AND PERFORMED PROPERLY. VISUAL INSPECTION OBSERVED SLIGHT KINK DAMAGE ON BOTH RECEIVED LEADS. THE KINK DAMAGE IS ASSUMED TO HAVE OCCURRED DURING EXPLANT. NO OTHER DAMAGES OR ANOMALIES WERE OBSERVED THROUGHOUT THE LEADS. THE LEAD MODEL 800045 HAS BEEN DISCONTINUED AND HAS NOT BEEN DISTRIBUTED SINCE 2018. FOLLOWING THE LEAD REVISION, THE REACTIV8 SYSTEM WAS ACTIVATED TO ALLOW THE PATIENT TO INITIATE BILATERAL STIMULATION (WHEN INITIATED BY THE PATIENT).

    Additional Manufacturer Narrative · 0

    MML # (B)(4). OTHER DEVICE REPLACED: MODEL: 8000-45, DESCRIPTION: REACTIV8 IMPLANTABLE STIMULATION LEAD, SERIAL NUMBER:(B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE TO REPLACE BOTH LEADS. THE RIGHT LEAD HAD A PARTIAL OUT-OF-RANGE/LOW-IMPEDANCE CONDITION. THE RIGHT LEAD IS PROGRAMMABLE TO ANOTHER WORKING ELECTRODE; HOWEVER, THE PATIENT ELECTED TO HAVE BOTH LEADS REPLACED TO ENSURE MRI (MAGNETIC RESONANCE IMAGING) COMPATIBILITY. THE REVISION PROCEDURE AND REPLACEMENT LEADS WERE COMPLETED WITHOUT COMPLICATIONS. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THE PATIENT REPORTEDLY HAS ACHIEVED EXCELLENT BENEFIT FROM REACTIV8 THERAPY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE TO REPLACE BOTH LEADS. THE RIGHT LEAD HAD A PARTIAL OUT-OF-RANGE/LOW-IMPEDANCE CONDITION. THE RIGHT LEAD IS PROGRAMMABLE TO ANOTHER WORKING ELECTRODE; HOWEVER, THE PATIENT ELECTED TO HAVE BOTH LEADS REPLACED TO ENSURE MRI (MAGNETIC RESONANCE IMAGING) COMPATIBILITY. THE REVISION PROCEDURE AND REPLACEMENT LEADS WERE COMPLETED WITHOUT COMPLICATIONS. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THE PATIENT REPORTEDLY HAS ACHIEVED EXCELLENT BENEFIT FROM REACTIV8 THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2210049 REACTIV8 REACTIV8 IMPLANTABLE STIMULATION LEAD QLK MAINSTAY MEDICAL LIMITED 8000-45 05391527772002

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male