BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRATA NSC LUMBOPERITONEAL SHUNT KIT

    MDR report key: 7000811 · Received November 3, 2017

    Report

    Report Number
    2021898-2017-00559
    Event Type
    Malfunction
    Date Received
    November 3, 2017
    Date of Event
    October 6, 2017
    Report Date
    December 27, 2017
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    UDI-DI
    00643169010789
    PMA / PMN Number
    K091312
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE RETURNED VALVE WAS RECEIVED WITHIN THE PRODUCT TRAY. ALL PERFORMANCE LEVELS COULD BE SET WITH A SINGLE ATTEMPT, AND THE VALVE DID NOT SPONTANEOUSLY CHANGE LEVELS DURING THE COURSE OF ANALYSIS. THEREFORE THE CONDITIONS OF THIS COMPLAINT COULD NOT BE VERIFIED BY LABORATORY PERSONNEL. ALL VALVES ARE 100% TESTED AT THE TIME OF MANUFACTURE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO CHANGE PRESET PRESSURE BUT FAILED. A BACK-UP LUMBAR PERITONEAL VALVE WAS USED TO SET UP PRESSURE. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUE. ADDITIONAL INFORMATION RECEIVED REPORTED THAT WHEN THE MANUFACTURER'S REPRESENTATIVE (REP) RECEIVED THE PRODUCT AND ATTEMPTED TO ADJUST THE SETTING, AND THEY COULD ADJUST IT. THE SETTING WAS AT PERFORMANCE LEVEL 2.5. THE REP THOUGHT PERSONALLY THAT THE DOCTOR TRIED TO ADJUST BY ROTATING CLOCKWISE, AND THE SETTING WAS COMING AND GOING BETWEEN PERFORMANCE LEVEL 2.0 AND 2.5 SO THEN THE DOCTOR MIGHT HAVE THOUGHT THAT THE SETTING WAS UNAVAILABLE TO BE CHANGED BECAUSE THE INITIAL SETTING WAS USUALLY PERFORMANCE LEVEL 0.5. THE DOCTOR REPORTED THAT THE SETTING PRESSURE WAS UNAVAILABLE TO BE ADJUSTED AT FIRST, HOWEVER, THE REP CONFIRMED THE DETAILS. THEY HEARD THAT THE SETTING WOULD BE SET BETWEEN PERFORMANCE LEVEL 2.0 AND 2.5, AND THE DOCTOR UNDERSTOOD THE SETTING. IT WAS NOTED THAT THE PERFORMANCE LEVEL WAS ABLE TO BE SET WITHIN THE BLUE RANGE EXCEPT 2.0. ONLY 2.0 WAS NOT ABLE TO BE SET WITHIN THE BLUE RANGE, BUT 2.0 WAS ABLE TO BE SET WITHIN THE WHITE RANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    778946 STRATA NSC LUMBOPERITONEAL SHUNT KIT SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY 44421 E27073 00643169010789

    Patients

    Seq Age Sex Outcome Treatment
    1