BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEDIATRIC HAKIM VALVE UNIT ONLY YELLOW, MEDIUM

    MDR report key: 795633 · Received December 13, 2006

    Report

    Report Number
    9612007-2006-00048
    Event Type
    Injury
    Date Received
    December 13, 2006
    Date of Event
    November 20, 2006
    Report Date
    December 12, 2006
    Manufacturer
    INTEGRA NEUROSCIENCES IMPLANTS S.A.
    Product Code
    JXG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE THE DEVICE HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITATIED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    THE USER FACILITY HAS REPORTED THAT A PEDIATRIC HAKIM VALVE THAT WAS IMPLANTED INTO A NEONATE PATIENT IN 2006 WAS EXPLANTED 22 DAYS LATER. THE PHYSICIAN THINKS THAT THE PRESSURE IN THE BRAIN IS TOO HIGH AND THAT THE VALVE WAS NOT REMOVING ENOUGH FLUID. THE PATIENT'S WEIGHT IS REPORTED TO BE 1.6KG. A REPLACEMENT 902-143 DEVICE WAS IMPLANTED AT THE SAME TIME AS THE EXPLANT. THE EXPLANTED DEVICE IS AVAILABLE FOR RETURN AND EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PEDIATRIC HAKIM VALVE UNIT ONLY YELLOW, MEDIUM DP VALVE JXG INTEGRA NEUROSCIENCES IMPLANTS S.A. * 12063662

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention