BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REACTIV8

    MDR report key: 14604709 · Received June 6, 2022

    Report

    Report Number
    3013017877-2022-00007
    Event Type
    Malfunction
    Date Received
    June 6, 2022
    Date of Event
    May 11, 2022
    Report Date
    September 27, 2022
    Manufacturer
    MAINSTAY MEDICAL LIMITED
    Product Code
    QLK
    PMA / PMN Number
    P190021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    MML REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    MML REFERECNE NUMBER (B)(4). CORRECRTED H6- FDA CODES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 TO REMOVE AND REPLACE THE RIGHT PERCUTANEOUS STIMULATION LEAD (ORIGINAL MODEL 8000-45) DUE TO PROGRESSIVE LOSS OF LEAD ELECTRODES. THE LEFT PERCUTANEOUS STIMULATION LEAD (ALSO A 8000-45 ORIGINAL LEAD) AND THE IMPLANTABLE PULSE GENERATOR (IPG) ARE FUNCTIONAL. HOWEVER, THEY WERE REPLACED AS A PRECAUTIONARY DUE TO THE LEFT LEAD IS ALSO THE OLD LEAD MODEL. THE PATIENT WAS IMPLANTED WITH THE REACTIV8 SYSTEM ON (B)(6) 2017. THE REVISION SURGERY WAS SUCCESSFUL, WITH NO REPORT OF PATIENT HARM OR INJURY RESULTING FROM THE SURGERY. THE REACTIV8 SYSTEM WAS RETURNED TO MML FOR ANALYSIS. THE REPORTED ISSUE WAS CONFIRMED ON THE RIGHT LEAD. VISUAL INSPECTION REVEALED ALL WIRES OF THE COIL FRACTURED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 TO REMOVE AND REPLACE THE RIGHT PERCUTANEOUS STIMULATION LEAD (ORIGINAL MODEL 8000-45) DUE TO PROGRESSIVE LOSS OF LEAD ELECTRODES. THE LEFT PERCUTANEOUS STIMULATION LEAD (ALSO A 8000-45 ORIGINAL LEAD) AND THE IMPLANTABLE PULSE GENERATOR (IPG) ARE FUNCTIONAL. HOWEVER, THEY WERE REPLACED AS A PRECAUTIONARY DUE TO THE LEFT LEAD IS ALSO THE OLD LEAD MODEL. THE PATIENT WAS IMPLANTED WITH THE REACTIV8 SYSTEM ON (B)(6) 2017. THE REVISION SURGERY WAS SUCCESSFUL, WITH NO REPORT OF PATIENT HARM OR INJURY RESULTING FROM THE SURGERY. THE REACTIV8 SYSTEM WAS RETURNED TO MML FOR ANALYSIS. THE REPORTED ISSUE WAS CONFIRMED ON THE RIGHT LEAD. VISUAL INSPECTION REVEALED ALL WIRES OF THE COIL FRACTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227123 REACTIV8 REACTIVE PERCUTANEOUS STIMULATION LEAD QLK MAINSTAY MEDICAL LIMITED 8000-45

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Female