BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PROGRAMMABLE VALVE

    MDR report key: 2250138 · Received September 15, 2011

    Report

    Report Number
    1226348-2011-00349
    Event Type
    Injury
    Date Received
    September 15, 2011
    Date of Event
    August 18, 2011
    Manufacturer
    CODMAN AND SHURTLEFF - MEDOS
    Product Code
    JXG
    PMA / PMN Number
    K980778
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION A FOLLOW UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION IT WAS NOTED THAT A SMALL NICK WAS NOTED AT ON THE BASE OF THE SILICONE NEAR THE CUT. THIS COULD HAVE HAPPENED DURING IMPLANTATION/EX-PLANTATION OF THE VALVE. PRIOR TO DISTRIBUTION THE DEVICE WAS TESTED FOR LEAKS AND PASSED THE TEST. A REVIEW OF THE DEVICE HISTORY RECORDS CONFIRMED THAT THIS DEVICE CONFORMED TO THE REQUIRED SPECIFICATIONS PRIOR TO DISTRIBUTION. THE ROOT CAUSE OF THE PROBLEM COULD HAVE BEEN DUE TO A SHARP OBJECT COMING INTO CONTACT WITH THE SILICONE HOUSING DURING IMPLANTATION OR EX-PLANTATION, BUT THIS COULD NOT BE DETERMINED. IT IS ALSO NOTED IN THE INSTRUCTIONS FOR USE THAT SILICONE HAS A LOW TEAR RESISTANCE AND HEALTH CARE USERS SHOULD USE EXTREME CARE. 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 SINCE THE PATIENT#146'S CONDITION DID NOT IMPROVE THE DEVICE WAS REVISED. DURING THE REVISION IT WAS NOTED THAT THE SILICONE HOUSING WAS DAMAGED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1