BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTA® SHUNT KIT, REGULAR, PL 1.5

    MDR report key: 4123562 · Received September 26, 2014

    Report

    Report Number
    2021898-2014-00386
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    August 31, 2014
    Report Date
    August 31, 2014
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K902783
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED. THEREFORE AN EVALUATION OF THE DEVICE PERFORMANCE WAS NOT POSSIBLE. A REVIEW OF THE MANUFACTURING RECORDS SHOWED NO ANOMALIES. ALL VALVES ARE 100% TESTED AT THE TIME OF MANUFACTURE. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE VALVE WAS PATENT. IT MET THE REQUIREMENTS FOR SIPHON, REFLUX, PRESSURE-FLOW, AND PRE-IMPLANTATION TESTING. HOWEVER, IT DID NOT MEET THE REQUIREMENTS FOR LEAK TESTING DUE TO A LARGE TEAR IN THE TOP MEMBRANE OF THE DELTA CHAMBER. IT IS UNKNOWN HOW OR WHEN THIS DAMAGE OCCURRED. THE INSTRUCTIONS FOR USE THAT ACCOMPANY THE DEVICE CAUTION THAT CARE SHOULD BE TAKEN IN HANDLING THE VALVES AS SILICONE HAS A LOW CUT AND TEAR RESISTANCE. THE RETURNED PERITONEAL CATHETER MET THE SPECIFICATIONS FOR PATENCY AND LEAK TESTING. A REVIEW OF THE MANUFACTURING RECORDS SHOWED NO ANOMALIES. ALL VALVES ARE 100% TESTED AT THE TIME OF MANUFACTURE. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT DURING THE PREIMPLANTATION TEST THE PHYSICIAN FOUND THAT THE VALVE WAS LEAKING FROM THE SIPHON CONTROL DEVICE ON THE VALVE. A NEW DEVICE WAS USED FOR THE SURGERY AND THERE WAS NO IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602215 DELTA® SHUNT KIT, REGULAR, PL 1.5 SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY D52673

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR