BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIDEKICK 2

    MDR report key: 20359570 · Received October 3, 2024

    Report

    Report Number
    3006630150-2024-06591
    Event Type
    Malfunction
    Date Received
    October 3, 2024
    Date of Event
    September 12, 2024
    Report Date
    April 11, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    GXI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    RFK-C101018S-ZK2-P LN: 34377095. THE RETURNED SIDEKICK CANNULA WAS ANALYZED, AND VISUAL INSPECTION OF THE CANNULA REVEALED THAT THE TIP HAS BROKEN OFF. WITH ALL THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC CONCLUDES THAT THE REPORTED EVENT OF NEEDLE BROKE OFF WAS CONFIRMED. THE TIP OF THE NEEDLE WAS REPORTED TO HAVE REMAINED INSIDE THE PATIENT. RECORD REVIEW DID NOT REVEAL ANY CONTRIBUTING FACTOR TO THE REPORTED COMPLAINT. THEREFORE, THIS INVESTIGATION IS UNABLE TO DETERMINE A PROBABLE CAUSE FOR THE COMPLAINT.

    Additional Manufacturer Narrative · 0

    CORRECTION TO THE INITIAL MDR IN BLOCK B2.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A RADIOFREQUENCY ABLATION (RFA) PROCEDURE, THE NEEDLE BROKE OFF INTO THE LUMBAR REGION OF THE PATIENT. THE TIP OF THE NEEDLE REMAINED INSIDE THE PATIENT; HOWEVER, NO COMPLICATIONS WERE REPORTED. THE PATIENT WAS REFERRED TO A SURGEON TO HAVE THE SEGMENT REMOVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A RADIOFREQUENCY ABLATION (RFA) PROCEDURE, THE NEEDLE BROKE OFF INTO THE LUMBAR REGION OF THE PATIENT. THE TIP OF THE NEEDLE REMAINED INSIDE THE PATIENT; HOWEVER, NO COMPLICATIONS WERE REPORTED. THE PATIENT WAS REFERRED TO A SURGEON TO HAVE THE SEGMENT REMOVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A RADIOFREQUENCY ABLATION (RFA) PROCEDURE, THE NEEDLE BROKE OFF INTO THE LUMBAR REGION OF THE PATIENT. THE TIP OF THE NEEDLE REMAINED INSIDE THE PATIENT; HOWEVER, NO COMPLICATIONS WERE REPORTED. THE PATIENT WAS REFERRED TO A SURGEON TO HAVE THE SEGMENT REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2015605 SIDEKICK 2 PROBE, RADIOFREQUENCY LESION GXI BOSTON SCIENTIFIC NEUROMODULATION CORPORATION RFK-C101018S-ZK2-P 34377095

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| O