BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTEGRAL LUMBAR DRAINAGE SET (ILDS)

    MDR report key: 11376570 · Received February 24, 2021

    Report

    Report Number
    9612007-2021-00010
    Event Type
    Injury
    Date Received
    February 24, 2021
    Date of Event
    January 23, 2021
    Report Date
    March 12, 2021
    Manufacturer
    INTEGRA NEUROSCICENCS IMPLANTS SA
    Product Code
    JXG
    PMA / PMN Number
    K924600
    Report Source
    Manufacturer report
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    THE LUMBAR DRAIN 910420 WAS NOT RETURNED FOR EVALUATION; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED. LOT NUMBER INFORMATION HAS BEEN PROVIDED; THEREFORE, MANUFACTURING RECORDS WERE REVIEWED AND FOUND NO ANOMALIES. WITHOUT ACTUAL DEVICE TO ANALYZE, THE COMPLAINT IS UNVERIFIABLE AND ITS EXACT ROOT CAUSE COULD NOT BE DETERMINED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE HOSPITAL: PATIENT WAS A MALE OVER THE AGE OF 70 YEARS WITH MUCH ARTHROSIS; SURGEON BELIEVES THERE WAS LITTLE SPACE TO INTRODUCE CATHETERS DUE TO THE PATIENT¿S ARTHROSIS, AND ARTHROSIS MIGHT HAVE CUT THE CATHETERS DUE TO PATIENT¿S FURTHER MOVEMENTS. IT IS ALSO POSSIBLE THAT WITH SUCH A CHALLENGING ANATOMY, THE TUOHY NEEDLE MAY HAVE CUT THE CATHETER A BIT DURING INSERTION, WEAKENING IT, AND PRESSURE OF VERTEBRAE AGAINST THE CATHETER MAY LEAD TO MIGRATION TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Description of Event or Problem · 0

    N/A.

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT WAS DISCARDED AS PER CUSTOMER. HOWEVER, AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THIS IS 1OF 2 REPORTS FOR THE 1ST DRAIN PLACED, WHICH IS LINKED TO MFG REPORT NUMBER 9612007-2021-00011: A FACILITY REPORTED THAT TWO EXTERNAL LUMBAR DRAINS (PRODUCT ID 910420) WERE PLACED IN THE PATIENT AND BOTH ENCOUNTERED THE SAME PROBLEM. THE FIRST DRAIN NO LONGER DRAINED THE NEXT DAY, SO THEY REINSERTED A NEW DRAIN. THERE WERE NO PROBLEMS PERIOPERATIVELY, UNTIL SEVERAL DAYS AFTER THE SECOND DRAIN WAS PLACED, WHEN IT WAS OBSERVED THAT THERE WAS "LACK OF PERMEABILITY OF THE DRAIN AND LEAKAGE AROUND THE SKIN OPENING OF THE DRAIN". THE SURGEON HAD TO MAKE A LAMINECTOMY TO THE PATIENT BETWEEN L4 AND L5 TO TAKE BACK THE PARTS OF THE DRAINS WHICH MIGRATED IN THE EXTRA DURAL PART. THE DRAINS HAD BEEN PUT BETWEEN THE L5 AND S1. THE CATHETERS WERE BOTH CUT. THE PATIENT IS A MALE (MORE THAN 70 YEARS OLD) WITH A LOT OF ARTHROSIS. THE SURGEON THINK THAT THE CATHETERS HAVE BEEN CUT BECAUSE THERE WAS LITTLE PLACE TO INTRODUCE THEM DUE TO THE ARTHROSIS OF THE PATIENT, AND AS THE PATIENT WAS NOT IMMOBILE IN ORL SERVICE, THE ARTHROSIS MIGHT HAVE CUT THE CATHETERS BECAUSE OF THE MOVEMENT OF THE PATIENT. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272606 INTEGRAL LUMBAR DRAINAGE SET (ILDS) EXTERNAL DRAINAGE SYSTEMS JXG INTEGRA NEUROSCICENCS IMPLANTS SA 0218268

    Patients

    Seq Age Sex Outcome Treatment
    1