BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REACTIV8

    MDR report key: 19746961 · Received July 15, 2024

    Report

    Report Number
    3013017877-2024-00052
    Event Type
    Malfunction
    Date Received
    July 15, 2024
    Date of Event
    June 18, 2024
    Report Date
    September 7, 2024
    Manufacturer
    MAINSTAY MEDICAL LIMITED
    Product Code
    QLK
    UDI-DI
    05391527772064
    PMA / PMN Number
    P190021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MML REFERENCE#: (B)(4). OTHER DEVICE REPLACED. MODEL: 5100. DESCRIPTION: REACTIV8 IMPLANTABLE PULSE GENERATOR. SERIAL NUMBER: (B)(6). THE LEAD ASSEMBLIES AND IPG WERE RETURNED AND EVALUATED. THE REPORTED ISSUE WAS VERIFIED. THE ANALYSIS CONFIRMED LEAD CONDUCTOR FRACTURES WERE THE CAUSE OF THE HIGH IMPEDANCE CONDITIONS OBSERVED WITH THE RETURNED PERCUTANEOUS STIMULATION LEADS. VISUAL INSPECTION OF THE IPG CONFIRMED THAT BOTH IPG HEADER SCREWS WERE OUT OF PLACE, BUT THE IPG PASSED FUNCTIONAL TESTING. THE IPG PERFORMED PROPERLY.

    Additional Manufacturer Narrative · 0

    MML REFERENCE (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY DUE TO THE PROGRESSION OF OUT-OF-RANGE/HIGH IMPEDANCE FAILURE ON BOTH LEADS. THE DEVICE WAS REMOVED EXCEPT FOR A SMALL FRAGMENT OF THE LEFT LEAD TIP, WHICH WAS LEFT INSIDE THE PATIENT. UNRELATED TO THE REPORTED ISSUE, THE IMPLANTABLE PULSE GENERATOR (IPG) WAS FUNCTIONAL BUT REPLACED DUE TO THE SURGEON COULD NOT USE THE SET SCREW ON THE IPG HEADER AFTER INSERTING THE LEADS INTO THE IPG. TWO NEW LEADS AND IPG WERE IMPLANTED SUCCESSFULLY. THERE WAS NO REPORT OF PATIENT HARM OR INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY DUE TO THE PROGRESSION OF OUT-OF-RANGE/HIGH IMPEDANCE FAILURE ON BOTH LEADS. THE DEVICE WAS REMOVED EXCEPT FOR A SMALL FRAGMENT OF THE LEFT LEAD TIP, WHICH WAS LEFT INSIDE THE PATIENT. UNRELATED TO THE REPORTED ISSUE. THE IMPLANTABLE PULSE GENERATOR WAS FUNCTIONAL BUT REPLACED DUE TO THE SURGEON COULD NOT USE THE SET SCREW ON THE IPG HEADER AFTER INSERTING THE LEADS INTO THE IPG. TWO NEW LEADS AND IPG WERE IMPLANTED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722688 REACTIV8 REACTIV8 PERCUTANEOUS STIMULATION LEAD QLK MAINSTAY MEDICAL LIMITED 8145 05391527772064

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Female