BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REACTIV8

    MDR report key: 20185617 · Received September 10, 2024

    Report

    Report Number
    3013017877-2024-00066
    Event Type
    Injury
    Date Received
    September 10, 2024
    Date of Event
    July 8, 2024
    Report Date
    December 13, 2024
    Manufacturer
    MAINSTAY MEDICAL LIMITED
    Product Code
    QLK
    UDI-DI
    05391527772064
    PMA / PMN Number
    P190021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MML REFERENCE # (B)(4).

    Additional Manufacturer Narrative · 0

    MML REFERENCE # (B)(4). ALTHOUGH REQUESTED, NO IMAGES WERE AVAILABLE OR EVIDENCE TO SUPPORT THE INCORRECT POSITION OR MIGRATION OF THE INITIAL LEADS IMPLANTED. THE DEVICE WAS RETURNED. THERE WAS NO ALLEGATION AGAINST THE LEAD'S FUNCTIONALITY. THE LEAD PASSED FUNCTIONAL TESTING, AND VISUAL INSPECTION OBSERVED NO DAMAGES OR ANOMALIES. THE REPORTED ISSUE WAS NOT CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN THE INITIAL IMPLANT PROCEDURE OF THE REACTIVE SYSTEM WAS COMPLETED, AN X-RAY REVEALED THAT THE LEADS WERE NO LONGER POSITIONED CORRECTLY. THE INCISION HAD TO BE REOPENED, AND TWO NEW LEADS AT THE SURGEON'S REQUEST WERE IMPLANTED WITHOUT COMPLICATIONS FOR THE PATIENT. THERE WAS NO REPORT OF PATIENT HARM OR INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN THE INITIAL IMPLANT PROCEDURE OF THE REACTIV8 SYSTEM WAS COMPLETED, AN X-RAY REVEALED THAT THE LEADS WERE NO LONGER POSITIONED CORRECTLY. THE INCISION HAD TO BE REOPENED, AND TWO NEW LEADS AT THE SURGEON'S REQUEST WERE IMPLANTED WITHOUT COMPLICATIONS FOR THE PATIENT. THERE WAS NO REPORT OF PATIENT HARM OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251660 REACTIV8 REACTIV8 IMPLANTABLE STIMULATION LEAD QLK MAINSTAY MEDICAL LIMITED 8145 05391527772064

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other