BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REACTIVI8

    MDR report key: 16293875 · Received February 3, 2023

    Report

    Report Number
    3013017877-2023-00001
    Event Type
    Malfunction
    Date Received
    February 3, 2023
    Date of Event
    January 4, 2023
    Report Date
    February 3, 2023
    Manufacturer
    MAINSTAY MEDICAL LIMITED
    Product Code
    QLK
    UDI-DI
    05391527772064
    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 #(B)(4). CORRECTED B4: DATE OF SUBMISSION OF THIS REPORT FROM 1/4/2023 TO 02/03/2023.

    Additional Manufacturer Narrative · 0

    MML REFERENCE # (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS UNABLE TO ACTIVATE STIMULATION. THE PATIENT STATED THAT HER BACK PAIN HAD BEEN ADVERSELY IMPACTED. THE FIELD CLINICAL ENGINEER (FCE) VERIFIED THAT THE RIGHT LEAD HAD PROGRESSIVE LOSS OF ELECTRODES DUE TO OUT-OF-RANGE. THE FCE REPROGRAMMED THE DEVICE TO USE UNILATERAL THERAPY ONLY TO COVER THE PERIOD UNTIL REVISION SURGERY CAN BE SCHEDULED. THERE WAS NO REPORT OF PATIENT HARM OR INJURY DUE TO THE EVENT. THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2023, TO REMOVE AND REPLACE THE RIGHT PERCUTANEOUS STIMULATION LEAD. THE LEAD ASSEMBLY WAS RETURNED AND EVALUATED. THE REPORTED ISSUE WAS VERIFIED. ANALYSIS CONFIRMED LEAD CONDUCTOR FRACTURES WERE THE CAUSE OF THE OUT-OF-RANGE IMPEDANCE CONDITIONS OBSERVED WITH THE RIGHT PERCUTANEOUS STIMULATION LEAD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS UNABLE TO ACTIVATE STIMULATION. THE PATIENT STATED THAT HER BACK PAIN HAD BEEN ADVERSELY IMPACTED. THE FIELD CLINICAL ENGINEER (FCE) VERIFIED THAT THE RIGHT LEAD HAD PROGRESSIVE LOSS OF ELECTRODES DUE TO OUT-OF-RANGE. THE FCE REPROGRAMMED THE DEVICE TO USE UNILATERAL THERAPY ONLY TO COVER THE PERIOD UNTIL REVISION SURGERY CAN BE SCHEDULED. THERE WAS NO REPORT OF PATIENT HARM OR INJURY DUE TO THE EVENT. THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2023, TO REMOVE AND REPLACE THE RIGHT PERCUTANEOUS STIMULATION LEAD. THE LEAD ASSEMBLY WAS RETURNED AND EVALUATED. THE REPORTED ISSUE WAS VERIFIED. ANALYSIS CONFIRMED LEAD CONDUCTOR FRACTURES WERE THE CAUSE OF THE OUT-OF-RANGE IMPEDANCE CONDITIONS OBSERVED WITH THE RIGHT PERCUTANEOUS STIMULATION LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    792922 REACTIVI8 REACTIV8 PERCUTANEOUS STIMULATION LEAD QLK MAINSTAY MEDICAL LIMITED 8145 05391527772064

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown