BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PROGRAMMABLE VALVE

    MDR report key: 10465893 · Received August 28, 2020

    Report

    Report Number
    3013886523-2020-00073
    Event Type
    Injury
    Date Received
    August 28, 2020
    Date of Event
    August 7, 2020
    Report Date
    August 7, 2020
    Manufacturer
    INTEGRA LIFESCIENCES SWITZERLAND SAR
    Product Code
    JXG
    PMA / PMN Number
    NI
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UDI #: (B)(4). THE HAKIM VALVE WAS RETURNED FOR EVALUATION: DEVICE HISTORY RECORD - LOT NUMBER 119386, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK ON 3 MAR. 2017. 48 PARTS RELEASED TO STOCK. FAILURE ANALYSIS - THE VALVE WAS VISUALLY INSPECTED; NO DEFECTS WERE NOTED. THE VALVE PASSED THE TEST FOR PROGRAMMING, OCCLUSION, LEAK, REFLUX AND PRESSURE. NO ROOT CAUSE COULD BE DETERMINED FOR THE PROBLEM REPORTED BY THE CUSTOMER AS THE TECHNICIAN COULD NOT CONFIRM ANY FUNCTIONAL PROBLEM WITH THE VALVE AT THE TIME OF INVESTIGATION. THE POSSIBLE ROOT CAUSE FOR THE ISSUE REPORTED BY THE CUSTOMER COULD BE DUE TO BIOLOGICAL DEBRIS AND PROTEIN BUILD UP THAT COULD INTERFERE WITH THE VALVE MECHANISM, BUT AT THE TIME OF INVESTIGATION NO ISSUES WERE NOTED.

    Additional Manufacturer Narrative · 1

    ATTEMPTS ARE BEING MADE TO OBTAIN ADDITIONAL INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A PHYSICIAN REPORTED THAT A CODMAN HAKIM PROGRAMMABLE VALVE WAS IMPLANTED VIA A V-P SHUNT ON AN UNKNOWN DATE WITH UNKNOWN INITIAL SETTINGS; HOWEVER, "A LITTLE UD AND SETTING COULD NOT BE CHANGED WERE OBSERVED." THE DEVICE WAS EXPLANTED ON (B)(6) 2020 AND REPLACED WITH A NEW ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    929534 HAKIM PROGRAMMABLE VALVE CHPV JXG INTEGRA LIFESCIENCES SWITZERLAND SAR

    Patients

    Seq Age Sex Outcome Treatment
    1