BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRO CHPV UNITIZED

    MDR report key: 17871281 · Received October 4, 2023

    Report

    Report Number
    3013886523-2023-00345
    Event Type
    Injury
    Date Received
    October 4, 2023
    Date of Event
    August 22, 2023
    Report Date
    November 16, 2023
    Manufacturer
    INTEGRA LIFESCIENCES SWITZERLAND SAR
    Product Code
    JXG
    PMA / PMN Number
    K053107
    Report Source
    Manufacturer report
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE HAKIM VALVE WAS RETURNED FOR EVALUATION: DHR - CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK FAILURE ANALYSIS - THE VALVE WAS VISUALLY INSPECTED: NO DEFECTS NOTED. THE VALVE PASSED THE TESTS FOR PROGRAMMING, OCCLUSION, LEAKS, REFLUX AND PRESSURE. ROOT CAUSE - NO ROOT CAUSE COULD BE DETERMINED FOR THE ISSUE REPORTED BY THE CUSTOMER AS THE TECHNICIAN COULD NOT CONFIRM ANY PROBLEMS WITH THE VALVE AT THE TIME OF INVESTIGATION.

    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.

    Description of Event or Problem · 0

    N/A

    Description of Event or Problem · 0

    A FACILITY REPORTED A HAKIM VALVE (ID 823114) WAS IMPLANTED VIA VENTRICULO-PERITONEAL SHUNT ON (B)(6) 2022. DESPITE SEVERAL SETTING CHANGES, THERE WAS NO IMPROVEMENT IN CLINICAL SIGNS (INCONTINENCE, WALKING DISORDERS WITH DISORIENTATION AND MEMORY DISORDERS); THEREFORE, THE VALVE WAS REMOVED AND REPLACED ON (B)(6 2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1525924 MICRO CHPV UNITIZED CHPV JXG INTEGRA LIFESCIENCES SWITZERLAND SAR 5936304

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male