BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUMBAR CAT ACCY KIT

    MDR report key: 13549028 · Received February 17, 2022

    Report

    Report Number
    9612007-2022-00004
    Event Type
    Injury
    Date Received
    February 17, 2022
    Date of Event
    September 29, 2021
    Report Date
    March 31, 2022
    Manufacturer
    INTEGRA NEUROSCICENCS IMPLANTS SA
    Product Code
    JXG
    UDI-DI
    10381780034124
    PMA / PMN Number
    K862513
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: D4, D9, G3, G6, H2, H3, H4, H6, H10. LUMBAR CAT ACCY KIT (910121) WAS NOT RETURNED FOR EVALUATION; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED. LOT NUMBER INFORMATION HAS BEEN PROVIDED; THEREFORE, DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND FOUND NO ANOMALIES. WITHOUT ACTUAL DEVICE TO INVESTIGATE, COMPLAINT IS CONSIDERED UNVERIFIABLE AND ITS EXACT ROOT CAUSE COULD NOT BE DETERMINED. THE MOST LIKELY CAUSE OF CATHETER FRACTURE IS THE CATHETER REMOVAL WHILE THE TUOHY NEEDLE IS STILL IN PLACE. AS STATED IN THE DEVICE INSTRUCTIONS FOR USE (BL 915003-REV 8), ¿TO AVOID CATHETER DAMAGE, DO NOT WITHDRAW THE CATHETER AFTER IT HAS BEEN INSERTED INTO THE NEEDLE. IF THE CATHETER MUST BE REMOVED, WITHDRAW THE NEEDLE AND CATHETER SIMULTANEOUSLY¿. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE IN THE FUTURE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Description of Event or Problem · 0

    MEDWATCH (MW5104457) WAS RECEIVED WITH THE FOLLOWING INFORMATION: "DURING ATTEMPTED LUMBAR DRAIN PLACEMENT, CATHETER UNABLE TO CONTINUE ADVANCING UPON CATHETER REMOVAL. PART OF THE CATHETER WAS RETAINED."

    Description of Event or Problem · 0

    MEDWATCH (MW5104457) WAS RECEIVED WITH THE FOLLOWING INFORMATION: "DURING ATTEMPTED LUMBAR DRAIN PLACEMENT, CATHETER UNABLE TO CONTINUE ADVANCING UPON CATHETER REMOVAL. PART OF THE CATHETER WAS RETAINED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    861948 LUMBAR CAT ACCY KIT N/A JXG INTEGRA NEUROSCICENCS IMPLANTS SA 910121 0223596 10381780034124

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown