BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRO CHPV W RICKHAM UNITIZED

    MDR report key: 12662270 · Received October 19, 2021

    Report

    Report Number
    3013886523-2021-00442
    Event Type
    Injury
    Date Received
    October 19, 2021
    Date of Event
    September 10, 2021
    Report Date
    December 16, 2021
    Manufacturer
    INTEGRA LIFESCIENCES SWITZERLAND SAR
    Product Code
    JXG
    PMA / PMN Number
    NI
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS:  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¿VALVE SPONTANEOUSLY RESETTING.¿ AS REPORTED BY THE CUSTOMER IS DUE TO THE VALVE RECEIVING A HARD KNOCK AND DISLODGING THE STATOR. THE ROOT CAUSE FOR THE CRACK AND BUMP MARK IN THE VALVE CASING IS DUE TO THE VALVE RECEIVING A HARD KNOCK. THE ROOT CAUSE OF THE CORROSION, COULD NOT BE CLEARLY DETERMINED GALVANIC CORROSION COULD NOT BE ESTABLISHED AS A DIRECT ROOT CAUSE FOR THOSE VALVES INVESTIGATED, HOWEVER IT WAS FOUND TO BE A CONTRIBUTING FACTOR WHEN TRAUMA TO THE VALVE WAS FOUND. CORROSION, WHEN IT ARISES, ONLY ARISES AFTER LONG TERM EXPOSURE TO CSF.

    Description of Event or Problem · 0

    N/A.

    Additional Manufacturer Narrative · 1

    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 · 1

    A FACILITY REPORTED A HAKIM PROGRAMMABLE VALVE MALFUNCTION: SPONTANEOUSLY RESETTING AT A HIGHER SETTING MULTIPLE TIMES. IN (B)(6) 2021 THE PATIENT PRESENTED WITH VENTRICULAR ENLARGEMENT, VOMITING AND HEADACHE. THE VALVE SHOWED A SETTING OF 200 AND IT WAS VERY DIFFICULT TO REPROGRAM. IN (B)(6) 2021 DURING A FOLLOW UP THE VALVE WAS VERY DIFFICULT TO REPROGRAM AGAIN AFTER MRI. TWICE LATER DURING (B)(6) 2021 THE PATIENT RETURNED WITH VOMITING/HEADACHE/VENTRICULAR ENLARGEMENT AND EACH TIME THE VALVE WAS AT HIGHER SETTING OF 200 - REPROGRAMMED WITH DIFFICULTY/MULTIPLE PROGRAMMERS TO 70, CONFIRMED WITH RADIOGRAPH EACH TIME. EVENTUALLY REPROGRAMMED TO 50 AS COULD NOT GET VALVE TO PROGRAM TO 70. THE VALVE WAS EXPLANTED AND REPLACED ON (B)(6) 2021. THE SYMPTOMS SUBSIDE AFTER REPLACEMENT. THE VALVE WAS USED TO TREAT HYDROCEPHALUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1559768 MICRO CHPV W RICKHAM UNITIZED CHPV JXG INTEGRA LIFESCIENCES SWITZERLAND SAR CTBCVG

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown