BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRATAMR VALVE

    MDR report key: 6447342 · Received March 30, 2017

    Report

    Report Number
    2021898-2017-00141
    Event Type
    Malfunction
    Date Received
    March 30, 2017
    Date of Event
    February 28, 2017
    Report Date
    October 17, 2017
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K152700
    Removal / Correction Number
    2021898-022217-001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS UNAVAILABLE FOR RETURN AS IT REMAINS IMPLANTED. 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. ADDITIONAL INFORMATION RECEIVED REPORTED THE DEVICE WAS IMPLANTED IN (B)(6) 2016. THE DEVICE WAS INITIALLY SET TO 1.0 (CONFIRMED BY X-RAY), BUT WAS THEN DIALED DOWN TO 0.5 (NOT CONFIRMED BY X-RAY) IN (B)(6). TOWARDS THE END OF (B)(6) 2017, THE SETTING WAS INCREASED TO 1.0 (NOT CONFIRMED BY X-RAY). ACCORDING TO THE REPORT, THE PATIENT CAME TO THE CLINIC IN (B)(6) WITH ENLARGED VENTRICLES. AN X-RAY SHOWED THE SETTING TO BE BETWEEN 0.5 AND 2.5. THE VALVE WAS RESET TO 1.0 AND THIS WAS CONFIRMED VIA X-RAY. REPORTEDLY, THE PATIENT HAD UNDERWENT MULTIPLE MRIS, 3 IN (B)(6) 2016, AND THEN 1 IN EACH (B)(6) 2017. IT WAS ADDED THE VALVE HAD BEEN BATHED IN VANCOMYCIN PRIOR TO IMPLANT. THE PATIENT WAS LAST SEEN IN (B)(6) AND THEY WERE DOING WELL. DEVICE AND PATIENT INFORMATION PROVIDED. PATENT AND DEVICE CODING UPDATED.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS UNAVAILABLE FOR RETURN. THEREFORE AN EVALUATION OF THE DEVICE PERFORMANCE WAS NOT POSSIBLE. A REVIEW OF THE MANUFACTURING RECORDS WAS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. ALL VALVES ARE 100% TESTED AT THE TIME OF MANUFACTURE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE DEVICE WAS IMPLANTED IN (B)(6) 2016. THE DEVICE WAS INITIALLY SET TO 1.0 (CONFIRMED BY X-RAY), BUT WAS THEN DIALED DOWN TO 0.5 (NOT CONFIRMED BY X-RAY) IN (B)(6). TOWARDS (B)(6) 2017, THE SETTING WAS INCREASED TO 1.0 (NOT CONFIRMED BY X-RAY). ACCORDING TO THE REPORT, THE PATIENT CAME TO THE CLINIC IN (B)(6) WITH ENLARGED VENTRICLES. AN X-RAY SHOWED THE SETTING TO BE BETWEEN 0.5 AND 2.5. THE VALVE WAS RESET TO 1.0 AND THIS WAS CONFIRMED VIA X-RAY. REPORTEDLY, THE PATIENT HAD UNDERWENT MULTIPLE MRIS, 3 IN (B)(6) 2016, AND THEN 1 IN EACH (B)(6) 2017. IT WAS ADDED THE VALVE HAD BEEN BATHED IN VANCOMYCIN PRIOR TO IMPLANT. THE PATIENT WAS LAST SEEN IN (B)(6) AND THEY WERE DOING WELL.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE PHYSICIAN WAS CONCERNED THAT THE PATIENT'S DEVICE WAS IN BETWEEN SETTINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228206 STRATAMR VALVE SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY E18556

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO