BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VPV SYSTEM

    MDR report key: 5104126 · Received September 25, 2015

    Report

    Report Number
    1226348-2015-10557
    Event Type
    Injury
    Date Received
    September 25, 2015
    Manufacturer
    CODMAN & SHURTLEFF, INC. / MEDOS S.A.
    Product Code
    JXG
    PMA / PMN Number
    PK061876
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NUMBERS 510 (K): K061876 & K050739. (B)(6). UPON COMPLETION OF THE INVESTIGATION A FOLLOW UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS EVALUATED BY THE PRODUCT MANAGER AND WAS FOUND TO BE FUNCTIONING PROPERLY. A REVIEW OF MANUFACTURING RECORDS WAS PERFORMED AND NO DISCREPANCIES WERE NOTED WHEN THE INSTRUMENT WAS RELEASED TO STOCK. THE ISSUE REPORTED BY THE CUSTOMER COULD NOT BE REPRODUCED. TRENDS WILL BE MONITORED FOR THIS OR SIMILAR COMPLAINTS. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Description of Event or Problem · 1

    OVER THE PREVIOUS 2 WEEKS THE PROGRAMMER IS CONSISTENTLY FAILING TO RECOGNIZE THE REPROGRAMMING, NECESSITATING AN XRAY FOR VERIFICATION. AT PRESENT, XRAYS INDICATE THE PROGRAMMER IS EFFECTIVELY CHANGING TO THE DESIRED PRESSURE SETTING, HOWEVER, THE ACOUSTIC VERIFICATION CONSISTENTLY FAILS TO INDICATE THAT THE SHUNT SETTING HAS BEEN CHANGED. FOLLOW UP RECEIVED ON 11-SEP-2015. NO OUTPATIENT CONSEQUENCES, BUT PATIENTS WOULD HAVE TO BE SENT TO XRAY FOR VERIFICATION PLACING ADDITIONAL COSTS ON HOSPITAL. UPON REPS INVESTIGATION, IT WAS NOTED THAT THE ACOUSTIC PRONG, LOCATED IN THE CENTRE OF PROGRAMMER HANDPIECE, IS STUCK IN A DEPRESSED POSITION, PREVENTING IT FROM COMING IN CONTACT WITH PATIENT SKIN. OVER 5 INSTANCES BETWEEN (B)(6) 2015. NO SPECIFIC DATES PROVIDED. REP WILL BRING REPLACEMENT DEVICE TO ACCOUNT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636853 VPV SYSTEM VALVE PROGRAMMER JXG CODMAN & SHURTLEFF, INC. / MEDOS S.A. CKLCD1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention