BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PROGRAMMABLE VALVE

    MDR report key: 18403441 · Received December 27, 2023

    Report

    Report Number
    3013886523-2023-00452
    Event Type
    Injury
    Date Received
    December 27, 2023
    Date of Event
    November 22, 2023
    Report Date
    February 9, 2024
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    JXG
    PMA / PMN Number
    K221840
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    HAKIM VALVE (ID 823100) WAS NOT RETURNED FOR EVALUATION (AS PER CUSTOMER, PRODUCT NOT AVAILABLE) AND LOT NUMBER INFORMATION HAS NOT BEEN PROVIDED; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED, AND DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIEWED. THE ROOT CAUSE(S) OF THE REPORTED ISSUE COULD NOT BE DETERMINED. HOWEVER, A POSSIBLE ROOT CAUSE FOR THE ISSUE REPORTED BY THE CUSTOMER COULD NOT BE CLEARLY DETERMINED BUT COULD BE LINKED TO SYSTEM DAMAGED OR BROKEN/ DEFECTIVE CONNECTION IN THE SHUNT SYSTEM (CSF LEAK). 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 · 0

    THIS IS 3 OF 3 REPORTS LINKED TO MFG REPORT NUMBERS: 3013886523-2023-00433, 3013886523-2023-00434. A PHYSICIAN REPORTED A HAKIM VALVE (ID 823100) WAS IMPLANTED IN 2015 VIA VENTRICULOPERITONEAL (VP) SHUNT WITH SETTING 90 MMH2O. IN 2019, THE VALVE WAS EXPLANTED DUE TO IS DYSFUNCTION THEREFORE, IT WAS REPLACED WITH ANOTHER VALVE (ID 823834) AND CONNECTOR (823053). ACCORDING TO THE INFORMATION PROVIDED, THE SPECIFIC DYSFUNCTION IS UNKNOWN. ALSO, IT IS UNKNOWN IF THE VALVE WAS SUSPECTED OF OBSTRUCTION OR BLOCKAGE AND IF THE PATIENT HAS ANY SIGNS AND SYMPTOMS DUE TO PRODUCT FAILURE. THIS REPORT IS FOR THE FIRST VALVE IMPLANTED IN 2015 (ID823100). THE SECOND VALVE (ID 823834) WAS REPORTED UNDER MFG REPORT NUMBER 3013886523-2023-00433.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2290167 HAKIM PROGRAMMABLE VALVE CHPV JXG INTEGRA LIFESCIENCES MANSFIELD

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Male HAKIM VALVE (ID 823834)| SHUNT CONNECTOR TITANIUM STRL (ID 823053)