BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REACTIV8

    MDR report key: 20103577 · Received August 29, 2024

    Report

    Report Number
    3013017877-2024-00060
    Event Type
    Injury
    Date Received
    August 29, 2024
    Date of Event
    July 31, 2024
    Report Date
    November 4, 2024
    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 REF#: (B)(4). B2- OTHER: PAIN/DISCOMFORT CORRECTION: THE PHYSICIAN REPOSITIONED THE IPG BY GOING DEEPER AT THE SAME INCISION SITE. THERE WAS NO CHANGE IN LOCATION. FOLLOWING THE IPG REPOSITIONING, THE REACTIV8 SYSTEM WAS ACTIVATED TO ALLOW THE PATIENT TO INITIATE BILATERAL STIMULATION (WHEN INITIATED BY THE PATIENT). THE DEVICE HISTORY RECORD WAS REVIEWED. NO RELEVANT ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 0

    MML REF#: (B)(4). B2- OTHER: PAIN/DISCOMFORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD LOST A LOT OF WEIGHT AND IS NOW HAVING PAIN/DISCOMFORT AT THE IMPLANTABLE PULSE GENERATOR (IPG) POCKET SITE. THE PATIENT UNDERWENT A SURGICAL PROCEDURE TO RELOCATE THE IPG. THERE WAS NO REPORT OF PATIENT HARM OR INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD LOST A LOT OF WEIGHT AND IS NOW HAVING PAIN/DISCOMFORT AT THE IMPLANTABLE PULSE GENERATOR (IPG) POCKET SITE. THE PATIENT UNDERWENT A SURGICAL PROCEDURE TO RELOCATE THE IPG. THERE WAS NO REPORT OF PATIENT HARM OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1314436 REACTIV8 REACTIV8 IMPLANTABLE PULSE GENERATOR QLK MAINSTAY MEDICAL LIMITED 5100 05391527770015

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other