BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REACTIV8

    MDR report key: 20243552 · Received September 18, 2024

    Report

    Report Number
    3013017877-2024-00069
    Event Type
    Injury
    Date Received
    September 18, 2024
    Date of Event
    February 28, 2024
    Report Date
    January 4, 2025
    Manufacturer
    MAINSTAY MEDICAL LIMITED
    Product Code
    QLK
    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 REFERENCE #:(B)(4). OTHER DEVICES EXPLANTED MODEL: 8145 DESCRIPTION: PERCUTANEOUS STIMULATION LEADS SERIAL NUMBERS: (B)(6). UDI: (B)(4).

    Additional Manufacturer Narrative · 0

    MML REFERENCE #: (B)(4). OTHER DEVICES EXPLANTED MODEL: 8145 DESCRIPTION: PERCUTANEOUS STIMILATIION LEADS SERIAL NUMBERS: (B)(6). UDI: (B)(4). THE DEVICES WERE RECEIVED AND EVALUATED. THERE WAS NO ALLEGATION AGAINST THE FUNCTIONALITY OF THE EXPLANTED DEVICES. A VISUAL INSPECTION WAS CARRIED OUT ON THE IPG, AND DRIED BLOOD WAS OBSERVED INSIDE BOTH CHANNELS OF THE IPG. THE IPG FAILED THE FUNCTIONAL TESTING. A POSSIBLE CAUSE WAS DRIED BLOOD IN BOTH CHANNEL PATHS, WHICH PREVENTED GOOD CONTACT BETWEEN THE LEAD ANODES AND IPG. THIS OBSERVATION IS NOT RELEVANT TO THE PAIN EXPERIENCED BY THE PATIENT. NO FUNCTIONAL TESTING COULD BE DONE ON THE LEADS BECAUSE THEY WERE DAMAGED FROM THE EXPLANT. UPDATED PATIENT INFORMATION, AND H6.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED DISCOMFORT AT THE IMPLANTABLE PULSE GENERATOR (IPG) POCKET SITE, WHICH CAUSED DIFFICULTY SITTING AND KEPT CATCHING ON THE FURNITURE. THEREFORE, THE PATIENT REQUESTED AN EXPLANT. REPORTEDLY, THE PATIENT HAS NO IMPROVEMENT IN PAIN AND FUNCTION. THE DEVICE WAS REMOVED WITHOUT ANY COMPLICATIONS. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THE DEVICE HISTORY RECORD WAS REVIEWED. NO NONCONFORMANCES WERE IDENTIFIED THAT WOULD HAVE CONTRIBUTED TO THE DISCOMFORT EXPERIENCED BY THE PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED DISCOMFORT AT THE IMPLANTABLE PULSE GENERATOR (IPG) POCKET SITE, WHICH CAUSED DIFFICULTY SITTING AND KEPT CATCHING ON THE FURNITURE. THEREFORE, THE PATIENT REQUESTED AN EXPLANT. REPORTEDLY, THE PATIENT HAS NO IMPROVEMENT IN PAIN AND FUNCTION. THE DEVICE WAS REMOVED WITHOUT ANY COMPLICATIONS. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THE DEVICE HISTORY RECORD WAS REVIEWED. NO NONCONFORMANCES WERE IDENTIFIED THAT WOULD HAVE CONTRIBUTED TO THE DISCOMFORT EXPERIENCED BY THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1360081 REACTIV8 REACTIV8 IMPLANTABLE PULSE GENERATOR QLK MAINSTAY MEDICAL LIMITED 5100

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female Other