BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REACTIV8

    MDR report key: 20221352 · Received September 15, 2024

    Report

    Report Number
    3013017877-2024-00068
    Event Type
    Injury
    Date Received
    September 15, 2024
    Date of Event
    August 16, 2024
    Report Date
    September 15, 2024
    Product Code
    QLK
    UDI-DI
    05391527770015
    PMA / PMN Number
    P190021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MML REFERENCE: (B)(4). B2-OTHER: DISCOMFORT/ RELOCATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) WAS PLACED AT THE MIDLINE, WHICH CAUSED DISCOMFORT AND PREVENTED IT FROM FULLY SETTLING INTO PLACE. REPORTEDLY, THE PATIENT WAS SEEING IMPROVEMENT WITH THE THERAPY. THE PATIENT UNDERWENT SURGERY TO MOVE THE IPG TO A MORE LATERAL LOCATION WITHOUT COMPLICATIONS. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. FOLLOWING THE IPG REPOSITIONING, THE REACTIV8 SYSTEM WAS ACTIVATED TO ALLOW THE PATIENT TO INITIATE BILATERAL STIMULATION (WHEN INITIATED BY THE PATIENT). THE MANUFACTURING RECORDS WERE REVIEWED, AND NO RELEVANT NON-CONFORMANCE'S WERE FOUND TO BE ASSOCIATED WITH THE DEVICE. THE DEVICE REMAINS IMPLANTED AND FUNCTIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1112398 REACTIV8 REACTIV8 IMPLANTABLE PULSE GENERATOR QLK 5100 05391527770015

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female Other