BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM INLINE PROGRAMMABLE VALVE SG

    MDR report key: 2863204 · Received December 10, 2012

    Report

    Report Number
    1226348-2012-00619
    Event Type
    Injury
    Date Received
    December 10, 2012
    Report Date
    November 21, 2012
    Manufacturer
    CODMAN AND SHURTLEFF - MEDOS
    Product Code
    JXG
    PMA / PMN Number
    K992173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    HISTORICALLY, FOR COMPLAINTS OF THIS NATURE, EXAMINATIONS OF THE VALVES HAVE REVEALED THE PRESENCE OF BIOLOGICAL DEBRIS WITHIN THE DEVICES WHICH HAVE INTERFERED WITH THEIR PROGRAMMING AND/OR PRESSURE CONTROL MECHANISMS. THE BIOLOGICAL DEBRIS HAS CAUSED THE RETURNED VALVES TO FAIL THE PROGRAMMING AND/OR PRESSURE TESTS AND APPEARS TO HAVE CAUSED THE DIFFICULTIES EXPERIENCED BY THE CUSTOMERS. REVIEWS OF THE DEVICE HISTORY RECORDS HAVE CONFIRMED THAT THE VALVES HAVE MET SPECIFICATIONS WHEN RELEASED TO STOCK. A FOLLOW UP REPORT WILL BE FILED IF THE INVESTIGATION OF THIS DEVICE REVEALS A RESULT DIFFERENT FROM THAT WHICH IS STATED ABOVE OR IF ANY FURTHER INFORMATION REGARDING THE CAUSE OR MODE OF FAILURE IS MADE AVAILABLE. OTHERWISE, THE COMPLAINT IS CONSIDERED TO BE CLOSED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION IT WAS NOTED THAT THE DEVICE RETURNED WAS THAT OF 82-3162 AND NOT THAT OF NS-9008 AS INITIALLY REPORTED. THE INVESTIGATION REVEALED THAT THE BASE OF THE NEEDLE CHAMBER HAD MOVED. THE DISTAL CONNECTOR WAS ALSO SLIGHTLY DAMAGED AS WELL. ADDITIONALLY, A HOLE WAS FOUND AT THE BASE OF THE NEEDLE CHAMBER SUGGESTING THAT A NEEDLE PUNCTURE HAS CAUSED THE BASE TO MOVE. THIS HOWEVER COULD NOT BE CONFIRMED. WHEN THE DEVICE WAS TESTED LEAKAGE WAS OBSERVED FROM THE NEEDLE CHAMBER. THE DEVICE ALSO FAILED PROGRAMMING AS THE CAM MECHANISM DID NOT MOVE. BIOLOGICAL DEBRIS WAS FOUND THROUGHOUT THE DEVICE. A REVIEW OF THE DEVICE HISTORY RECORDS CONFIRMED THAT THE DEVICE CONFORMED TO THE REQUIRED SPECIFICATIONS PRIOR TO DISTRIBUTION. BASED ON THE RESULTS OF THIS INVESTIGATION NO FURTHER ACTION IS REQUIRED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CLOSED.

    Description of Event or Problem · 1

    AFFILIATE REPORTED THAT THE DEVICE WOULD NOT REPROGRAM WHEN ATTEMPTED MULTIPLE TIMES OVER THE COURSE OF A FEW DAYS. AS A RESULT THE DEVICE WAS REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HAKIM INLINE PROGRAMMABLE VALVE SG SHUNT, CENTRAL NERVOUS SYSTEM COMPS JXG CODMAN AND SHURTLEFF - MEDOS CHGCWR

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention