BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATHETER LUMBO-PERITONEAL COMPLETE SET

    MDR report key: 2220649 · Received June 30, 2011

    Report

    Report Number
    3001587388-2011-00178
    Event Type
    Malfunction
    Date Received
    June 30, 2011
    Date of Event
    June 20, 2011
    Report Date
    June 24, 2011
    Manufacturer
    SOPHYSA
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    A VALVE, SM8 AND CATHETERS WERE IMPLANTED A YEAR AGO. AS THE PT SUFFERED FROM HYDROCEPHALUS, THE SURGEON DECIDED TO CHANGE THE PRESSURE SETTING. HE THEN REALIZED THE PROXIMAL CATHETER HAD BEEN SPLIT INTO TWO AROUND SPINOUS PROCESS WHERE HE THINKS THE CATHETER WOULD NOT BE CUT. HE EXCHANGED THE CATHETER, BUT COULD REMOVE ONLY THE HALF OF IT WHICH WAS CONNECTED TO THE VALVE. THE OTHER HALF OF THE CATHETER COULD NOT BE REMOVED AND STAYS IN THE PT'S BODY. HE WOULD LIKE TO KNOW THE REASON OF THIS EVENT. IN HIS OPINION, THE SHAPE OF THE LUMBAR PUNCTURE NEEDLE IS NOT GOOD AND THAT MIGHT HAVE CAUSED A SMALL DAMAGE ON THE CATHETER FIRST, WHICH GOT BIGGER LATER. (B)(6): A YEAR AGO, THE SURGEON SAID THAT THE LUMBAR PUNCTURE NEEDLE WAS DIFFICULT TO GET CONNECTED TO THE LUMBAR CATHETER. HE THEREFORE HAS BEEN USING OTHER COMPANY'S NEEDLE LATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CATHETER LUMBO-PERITONEAL COMPLETE SET LUMBO-PERITONEAL CATHETER JXG SOPHYSA LPS50 PENDING THE RETURN

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR