BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGAV SYSTEM W/CONTROL RESERVOIR

    MDR report key: 7728811 · Received July 27, 2018

    Report

    Report Number
    3004721439-2018-00149
    Event Type
    Malfunction
    Date Received
    July 27, 2018
    Report Date
    August 28, 2018
    Manufacturer
    CHRISTOPH MIETHKE GMBH & CO. KG
    Product Code
    JXG
    PMA / PMN Number
    K103003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AESCULAP INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF CHRISTOPH MIETHKE GMBH & CO. KG (MANUFACTURER). EXEMPTION NUMBER: E2017044. MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING.

    Additional Manufacturer Narrative · 0

    INVESTIGATION: NO PRODUCT RECEIVED FOR EXAMINATION. RESULT: AN INVESTIGATION WAS NOT POSSIBLE BECAUSE NO PRODUCT WAS SEND FOR EXAMINATION. ALSO THE UNDERLYING PRODUCT INFORMATION IS NOT SUFFICIENT TO DRAW CONCLUSIONS ABOUT COMPLAINTS IN THE PAST. HOWEVER, WE POINT OUT THAT IT IS IMPORTANT TO POSITION THE ADJUSTMENT TOOL ENTRALLY OVER THE VALVE. PLEASE KEEP IN MIND, THAT DESPITE OF A CORRECT USE OF THE ADJUSTMENT TOOL IT MAY CAN BE DIFFICULT TO ADJUST THE VALVE DUE TO A POSTOPERATIVE SWELLING OF THE SKIN WITHIN THE FIRST FEW DAYS.1 WHAT ACTUALLY HAS LED TO THE DIFFICULTIES IN ADJUSTING, DOES NOT EXPLAIN TO US, SINCE THIS WOULD REQUIRE AN EXAMINATION OF THE PRODUCT. HOWEVER, A PRODUCT HAS NOT BEEN SENT YET. FURTHER ACTIONS: BASED ON THE CURRENT INFORMATION, NO FURTHER ACTIONS ARE REQUIRED FROM OUR POINT OF VIEW.

    Description of Event or Problem · 0

    COUNTRY OF COMPLAINT: (B)(6). IT WAS REPORTED THAT PATIENT RECEIVED A VENTRICULOPERITONEAL SHUNT LAST YEAR. HE CAME BACK TO THE HOSPITAL WITH AMS AND CT SCAN SHOWED LARGER VENTRICLES. WE TAPPED THE SHUNT WITH NO INFECTION. WANTED TO CHANGE THE VALVE SETTING OF THE PROGRAMMABLE PROGAV VALVE TO A LOWER SETTING TO IMPROVE THE DRAINAGE, HOWEVER, WE COULD NOT CHANGE THE SETTING. PATIENT NEEDED TO BE TAKEN TO THE OR TO CHANGE THE VALVE. NO PATIENT INJURY REPORTED. NO DELAY IN SURGERY REPORTED. ADDITIONAL INTERVENTION TAKEN WAS TAKING PATIENT TO OR TO CHANGE VALVE. THE INITIAL SHUNT WAS PLACED ON (B)(6) 2018. THE EXPLANT DATE WAS (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569687 PROGAV SYSTEM W/CONTROL RESERVOIR PRO GAV JXG CHRISTOPH MIETHKE GMBH & CO. KG FV431T 20032043

    Patients

    Seq Age Sex Outcome Treatment
    1 Other