BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHPV RT ANG RESERVOIR UNITIZED

    MDR report key: 18530289 · Received January 17, 2024

    Report

    Report Number
    3013886523-2023-00467
    Event Type
    Injury
    Date Received
    January 17, 2024
    Date of Event
    December 21, 2023
    Report Date
    March 6, 2024
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    JXG
    UDI-DI
    10886704041542
    PMA / PMN Number
    K053107
    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

    THE HAKIM VALVE (ID 823148) WAS RETURNED FOR EVALUATION. DEVICE HISTORY RECORD (DHR) ¿ LOT 4113065, CONFORMED TO THE SPECIFICATIONS WHEN 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. THE CATHETER WAS IRRIGATED NO OCCLUSIONS NOTED. ROOT CAUSE ANALYSIS - NO ROOT CAUSE COULD BE DETERMINED FOR THE FAILURE ISSUE REPORTED BY THE CUSTOMER AS THE TECHNICIAN COULD NOT CONFIRM ANY PROBLEMS WITH THE VALVE AT THE TIME OF INVESTIGATION. A POSSIBLE ROOT CAUSE FOR THE ISSUE REPORTED BY THE CUSTOMER COULD BE DUE TO BIOLOGICAL DEBRIS AND PROTEIN BUILD UP INTERFERING WITH THE DEVICE.

    Description of Event or Problem · 0

    A PHYSICIAN REPORTED A HAKIM VALVE (ID 823148) WAS IMPLANTED IN A PATIENT WITH COMMUNICATING HYDROCEPHALUS VIA LUMBOPERITONEAL (LP) SHUNT ON UNKNOWN DATE WITH UNKNOWN SETTING. ON (B)(6) 2023, A REVISION SURGERY WAS PERFORMED DUE TO SUSPECTED OBSTRUCTION OF THE VALVE. THE VALVE AND VENTRICULAR CATHETER WERE EXPLANTED AND REPLACED ON (B)(6) 2023. ACCORDING TO INFORMATION PROVIDED, IT IS UNKNOWN IF THE VENTRICULAR CATHETER IS A COMPONENT OF THE HAKIM VALVE.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1712897 CHPV RT ANG RESERVOIR UNITIZED CHPV JXG INTEGRA LIFESCIENCES MANSFIELD 10886704041542

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown