BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROG VALVE INLINE W SG

    MDR report key: 19621044 · Received June 26, 2024

    Report

    Report Number
    3013886523-2024-00190
    Event Type
    Injury
    Date Received
    June 26, 2024
    Date of Event
    June 5, 2024
    Report Date
    September 13, 2024
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    JXG
    UDI-DI
    10381780519232
    PMA / PMN Number
    K221840
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: D4, D9, G3, G6, H2, H3, H4, H6, H11. THE HAKIM VALVE (ID 823162) WAS RETURNED FOR EVALUATION. DEVICE HISTORY RECORD (DHR) ¿ THE PRODUCT CODE 82-3162 WITH LOT 6331804, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK. FAILURE ANALYSIS - THE POSITION OF THE CAM WHEN VALVE WAS RECEIVED WAS ON SETTING 40 MMH2O. THE VALVE WAS VISUALLY INSPECTED; A TEAR MARK WAS NOTED IN THE NEEDLE CHAMBER. THE VALVE PASSED THE TEST FOR PROGRAMMING, OCCLUSION, REFLUX, SIPHON GUARD AND PRESSURE. ROOT CAUSE ANALYSIS - THE POSSIBLE ROOT CAUSE FOR THE ISSUE REPORTED BY THE CUSTOMER, COULD BE DUE TO BIOLOGICAL DEBRIS AND PROTEIN BUILD UP INTERFERING WITH THE VALVE. THE ROOT CAUSE FOR THE ¿TEAR MARK¿ COULD BE DUE A SHARP OR POINTED OBJECT COMING INTO CONTACT WITH THE VALVE IN VIEW OF THE TEAR MARK ON THE NEEDLE CHAMBER. AS NOTED IN THE SURGICAL PROCEDURE PRECAUTIONS SECTION IN INSTRUCTION FOR USE (IFU), SILICONE HAS A LOW CUT/TEAR RESISTANCE.

    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 PHYSICIAN REPORTED A HAKIM VALVE (ID 823162) WAS IMPLANTED VIA VENTRICULOPERITONEAL (VP) SHUNT ON UNKNOWN DATE WITH UNKNOWN SETTING DUE TO CONGENITAL HYDROCEPHALUS. DUE TO SUSPICION OF OBSTRUCTION, THE VALVE WAS REMOVED ON (B)(6) 2024 AND WAS REPLACED WITH ANOTHER VALVE ON AN UNKNOWN DATE. PRIMARY DISEASE IS MENINGITIS. THE PATIENT IS IN FOLLOW UP. BASED ON INFORMATION PROVIDED, IT IS UNKNOWN IF THE PATIENT EXPERIENCED ANY SIGNS AND SYMPTOMS DUE TO OBSTRUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1752454 PROG VALVE INLINE W SG CHPV WITH SG JXG INTEGRA LIFESCIENCES MANSFIELD 10381780519232

    Patients

    Seq Age Sex Outcome Treatment
    1 8 MO Male Required Intervention