BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REACTIV8

    MDR report key: 25174201 · Received May 14, 2026

    Report

    Report Number
    3021520203-2026-00057
    Event Type
    Injury
    Date Received
    May 14, 2026
    Date of Event
    April 14, 2026
    Report Date
    May 14, 2026
    Manufacturer
    MAINSTAY MEDICAL LIMITED
    Product Code
    QLK
    UDI-DI
    05391527770015
    PMA / PMN Number
    P190021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MML# (B)(4). OTHER DEVICE EXPLANTED. MODEL: 8145. DESCRIPTION: REACTIV8 IMPLANTABLE STIMULATION LEAD. SERIAL NUMBER: (B)(6). UDI# (B)(4).

    Description of Event or Problem · 0

    MAINSTAY MEDICAL LIMITED (MML) RECEIVED INFORMATION THAT THE DEVICE WAS EXPLANTED DUE TO PERSISTENT OOZING FROM THE WOUND AT THE IMPLANTABLE PULSE GENERATOR (IPG) SITE. NO MML REPRESENTATIVE WAS PRESENT DURING THE DEVICE EXPLANT. HOWEVER, THE ENTIRE REACTIV8 SYSTEM WAS REPORTED TO HAVE BEEN REMOVED WITHOUT COMPLICATIONS. A CULTURE WAS TAKEN, BUT THE RESULTS WERE NOT PROVIDED TO MML. IT IS ALSO UNKNOWN IF THE PATIENT WAS TREATED WITH ANTIBIOTICS. NO OTHER INFORMATION WAS PROVIDED. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THE DEVICE WAS NEVER SWITCHED ON POST-IMPLANT. THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, NO ACTUAL DEVICE ANALYSIS COULD BE PERFORMED. HOWEVER, THE DEVICE HISTORY RECORD, INCLUDING STERILIZATION, WAS REVIEWED. NO RELEVANT NONCONFORMANCES WERE FOUND THAT WOULD HAVE CONTRIBUTED TO THE ALLEGED WOUND-HEALING ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311943 REACTIV8 REACTIV8 IMPLANTABLE PULSE GENERATOR QLK MAINSTAY MEDICAL LIMITED 5100 05391527770015

    Patients

    Seq Age Sex Outcome Treatment
    1