BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REACTIV8

    MDR report key: 16297658 · Received February 3, 2023

    Report

    Report Number
    3013017877-2023-00002
    Event Type
    Injury
    Date Received
    February 3, 2023
    Date of Event
    January 11, 2023
    Report Date
    March 21, 2023
    Manufacturer
    MAINSTAY MEDICAL LIMITED
    Product Code
    QLK
    UDI-DI
    05391527770015
    PMA / PMN Number
    P190021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    MML REFERENCE#: (B)(4). OUTCOMES ATTRIBUTED TO ADVERSE EVENT: SURGICAL PROCEDURE TO REPOSITION THE DEVICE. CUSTOMER PHONE NUMBER: (B)(6).

    Additional Manufacturer Narrative · 0

    MML REFERENCE # (B)(4). B2 OTHER: SURGICAL PROCEDURE TO REPOSITION THE DEVICE. CUSTOMER PHONE NUMBER:(B)(6). 3/21/2023: UPDATED H6 CONCLUSION CODE. THE PATIENT WAS IMPLANTED WITH THE REACTIV8 SYSTEM ON (B)(6) 2022 AND WAS DOING WELL BEFORE THE REPORTED POCKET PAIN DISCOMFORT. THE MANUFACTURING RECORD OF THIS DEVICE WAS REVIEWED, AND NO RELEVANT NONCONFORMITIES WERE FOUND. THE X-RAYS IMAGES FROM THE POST-INITIAL IMPLANT AND PRE-SURGICAL PROCEDURE TO REPOSITION THE IPG REVEALED THE IPG WAS LOCATED IN A TYPICAL POSITION. PER THE IMPLANT AND PROGRAMMING MANUAL, A KNOWN RISK ASSOCIATED WITH SURGERY, IMPLANTATION OF A MEDICAL DEVICE, OR USE OF REACTIV8 IS ACUTE OR PERSISTENT PAIN, AND/OR DISCOMFORT DUE TO THE PRESENCE OF THE DEVICE. THERE IS NO FURTHER REPORT OF PAIN AFTER THE REPOSITIONING OF THE IPG.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED POCKET PAIN AT THE IMPLANTABLE PULSE GENERATOR (IPG) SITE. THE PATIENT UNDERWENT A SURGICAL PROCEDURE TO REPOSITION THE LOCATION OF THE IPG. THE EVENT WAS SUCCESSFUL, WITH NO REPORT OF PATIENT HARM OR INJURY. THE DEVICE REMAINS IMPLANTED AND FUNCTIONAL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED POCKET PAIN AT THE IMPLANTABLE PULSE GENERATOR (IPG) SITE. THE PATIENT UNDERWENT A SURGICAL PROCEDURE TO REPOSITION THE LOCATION OF THE IPG. THE EVENT WAS SUCCESSFUL, WITH NO REPORT OF PATIENT HARM OR INJURY. THE DEVICE REMAINS IMPLANTED AND FUNCTIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2082202 REACTIV8 REACTIV8 IMPLANTABLE PULSE GENERATOR (IPG) QLK MAINSTAY MEDICAL LIMITED 5100 05391527770015

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Female Other