BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMBAR CATHETER OPEN TIP

    MDR report key: 2941221 · Received January 18, 2013

    Report

    Report Number
    2021898-2013-00021
    Event Type
    Malfunction
    Date Received
    January 18, 2013
    Date of Event
    December 20, 2012
    Report Date
    December 24, 2012
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K831396
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NINETY-THREE CM OF THE CATHETER WAS RETURNED. THE CATHETER WAS PT. IT ALSO MET REQUIREMENTS FOR THE TENSILE STRENGTH AND ULTIMATE ELONGATION TESTS. IT DID NOT MEET REQUIREMENTS FOR THE LEAKAGE TEST. A TEAR WAS OBSERVED 47 CM AWAY FROM THE PROXIMAL END OF THE CATHETER. IT IS UNK HOW OR WHEN THIS DAMAGE OCCURRED. THE INSTRUCTIONS FOR USE THAT ACCOMPANY THE DEVICE CAUTION THAT LOW TEAR STRENGTH IS A CHARACTERISTIC OF MOIST UNREINFORCED SILICONE ELASTOMER MATERIALS. CARE MUST BE TAKEN WITH THE HANDLING AND PLACEMENT OF THE SILICONE ELASTOMER CATHETER TUBING TO AVOID CUTS, NICKS OR TEARS. A REVIEW OF MFG RECORDS SHOWED NO ANOMALIES.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT DURING THE IMPLANTATION SURGERY, A HOLE WAS FOUND ON THE LUMBAR CATHETER. IT WAS ALSO REPORTED THAT THERE WAS NOT IMPACT ON THE PT'S HEALTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28253 LUMBAR CATHETER OPEN TIP JXG - SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY

    Patients

    Seq Age Sex Outcome Treatment
    1