BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PROGRAMMABLE VALVE

    MDR report key: 12218252 · Received July 23, 2021

    Report

    Report Number
    3013886523-2021-00322
    Event Type
    Injury
    Date Received
    July 23, 2021
    Date of Event
    July 1, 2021
    Report Date
    July 23, 2021
    Manufacturer
    INTEGRA LIFESCIENCES SWITZERLAND SAR
    Product Code
    JXG
    PMA / PMN Number
    NI
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE HAKIM VALVE WAS NOT RETURNED FOR EVALUATION AND NO LOT NUMBER INFORMATION HAS BEEN PROVIDED; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED, AND MANUFACTURING RECORDS COULD NOT BE REVIEWED. THE CAUSE(S) OF THE DIFFICULTY REPORTED BY THE CUSTOMER COULD NOT BE DETERMINED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE IN THE FUTURE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Description of Event or Problem · 1

    A PHYSICIAN REPORTED THE HAKIM PROGRAMMABLE VALVE WAS IMPLANTED TO A PATIENT AFTER A CEREBRAL HEMORRHAGE VIA V-P SHUNT ON (B)(6) 2021 WITH A SETTING OF 180MMH2O. IT WAS REPORTED THAT A SUBDURAL HEMATOMA OCCURRED DUE TO OVER DRAINAGE. IT WILL BE SCHEDULED THAT SUBDURAL HEMATOMA WILL BE REMOVED AND CHPV (823110) WILL BE PLACED AT CHEST IN TANDEM WITH THE VALVE ON JUL 6, 2021. NO FURTHER INFORMATION WAS PROVIDED BY HOSPITAL

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1114021 HAKIM PROGRAMMABLE VALVE CHPV JXG INTEGRA LIFESCIENCES SWITZERLAND SAR

    Patients

    Seq Age Sex Outcome Treatment
    1