BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTA SHUNT KIT, REGULAR PERFORMANCE LEVEL 1.5

    MDR report key: 3131240 · Received May 23, 2013

    Report

    Report Number
    2021898-2013-00188
    Event Type
    Malfunction
    Date Received
    May 23, 2013
    Date of Event
    April 27, 2013
    Report Date
    May 1, 2013
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K902783
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS UNAVAILABLE FOR RETURN. THEREFORE, AN EVALUATION OF DEVICE PERFORMANCE WAS NOT POSSIBLE. A REVIEW OF THE MFG RECORDS SHOWED NO ANOMALIES. ALL OF OUR VALVES ARE 100% TESTED AT THE TIME OF MANUFACTURE.

    Additional Manufacturer Narrative · 1

    THE VALVE DID NOT MEET THE SPECIFICATIONS FOR PATENCY OR LEAK TESTING DUE TO A LARGE TEAR ON THE TOP OF THE RESERVOIR DOME. IT IS UNKNOWN HOW OR WHEN THIS DAMAGE OCCURRED. THE DAMAGE PRECLUDED SIPHON, REFLUX, PRESSURE-FLOW AND PRE-IMPLANTATION TESTING. 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. THERE WERE NO ANOMALIES NOTED WITH THE CATHETERS. THE VENTRICULAR AND PERITONEAL CATHETER PASSED PATENCY AND LEAK TESTING. A REVIEW OF THE MANUFACTURING RECORDS SHOWED NO ANOMALIES. ALL OF THE 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 SURGERY, THE PHYSICIAN FOUND THE DEVICE RESERVOIR TO BE LEAKING. ACCORDING TO THE REPORT, THE PHYSICIAN USED ANOTHER PRODUCT TO COMPLETE THE SURGERY. THE REPORT SATED THAT THERE WAS NO IMPACT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228675 DELTA SHUNT KIT, REGULAR PERFORMANCE LEVEL 1.5 JXG - SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY D29933

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR