BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK HAKIM PROGRAMMABLE VALVE

    MDR report key: 7027824 · Received November 14, 2017

    Report

    Report Number
    1226348-2017-10831
    Event Type
    Injury
    Date Received
    November 14, 2017
    Date of Event
    March 3, 2009
    Product Code
    JXG
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT SAMPLE WAS NOT RETURNED TO CODMAN AND NO LOT NUMBER INFORMATION HAS BEEN PROVIDED; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED AND MANUFACTURING RECORDS COULD NOT BE REVIEWED. THE CAUSE(S) OF THE DIFFICULTY REPORTED BY THE CUSTOMER COULD NOT BE DETERMINED. IF THE COMPLAINT SAMPLE BECOMES AVAILABLE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS OR SIMILAR COMPLAINTS. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IN THE LITERATURE ARTICLE ¿FATAL INTRACEREBRAL HEMORRHAGE AFTER REDUCING THE VALVE PRESSURE OF A VENTRICULO-PERITONEAL SHUNT¿ PUBLISHED ACTA NEUROCHIR (2009) 151:409¿410, DOI 10.1007/S00701-009-0224-6, IT WAS REPORTED THAT THIS (B)(6) MAN, WITH A HISTORY OF NORMAL PRESSURE HYDROCEPHALUS, HAD AN UNKNOWN CODMAN HAKIM PROGRAMMABLE VALVE INSERTED, FOLLOWING A PROGRAMMING ADJUSTMENT OF THE VALVE, HAD AN EXTENSIVE INTRACEREBRAL BLEED AND SUBSEQUENTLY DIED. PER THE ARTICLE: ¿WE REPORT THE OCCURRENCE OF INTRACRANIAL BLEEDING SOON AFTER ALTERING THE RESISTANCE SETTING OF A VENTRICULO-PERTONEAL SHUNT IN ORDER TO DRAW ATTENTION TO THE RISK OF THIS COMPLICATION. A (B)(6) MAN WAS ADMITTED BECAUSE OF PROGRESSIVE GAIT DISTURBANCE AND IMPAIRED COGNITION. HE HAD A VENTRICULO-PERITONEAL (VP)-SHUNT IMPLANTED FOR NORMAL PRESSURE HYDROCEPHALUS 3 YEARS BEFORE (CODMAN® BACTISEAL® EVD CATHETER WITH A CODMAN® HAKIM® PROGRAMMABLE VALVE SYSTEM, JOHNSON AND JOHNSON COMP., (B)(4)). A CT-SCAN OF THE BRAIN SHOWED A SLIGHT PROGRESSION OF THE VENTRICULAR ENLARGEMENT COMPARED WITH AN EARLIER CT SCAN. THIS WAS ATTRIBUTED TO INSUFFICIENT VENTRICULAR DRAINAGE AND IT WAS DECIDED TO CHANGE THE VP-SHUNT FROM A MEDIUM TO A LOW-PRESSURE STATE BY REDUCING THE PROGRAMMABLE VALVE RESISTANCE FROM 70 TO 40 MM H2O. FOUR DAYS LATER THE PATIENT DEVELOPED A RIGHT-SIDED HEMIPARESIS AND BECAME UNCONSCIOUS. A CT-SCAN SHOWED AN EXTENSIVE SUBDURAL EFFUSION AND INTRACEREBRAL HAEMORRHAGE IN THE LEFT HEMISPHERE. THE PATIENT DIED AFTER A FEW HOURS. ORAL ANTICOAGULATION WITH PHENPROCOUMON HAD BEEN CEASED WHEN HE WAS ADMITTED 4 DAYS BEFORE THE SHUNT PRESSURE WAS MANIPULATED. HIS INR HAD BEEN 2.6 AT THAT TIME AND WAS NOT RECHECKED THEREAFTER. HYPERTENSION WAS NOT SEEN AT ANY TIME.¿ AT THE TIME OF COMPLAINT ENTRY THERE IS NO CATALOGUE OR LOT NUMBER INFORMATION AVAILABLE. THIS SUBMISSION IS RELATED TO A LITERATURE ARTICLE DISCOVERED IN AN EFFORT TO SUPPORT THE CER SUBMISSION PROCESS, AS SUCH, THE ASSOCIATED TIME FRAME OF EVENT DATES INCLUDES BUT IS NOT LIMITED TO 20 YEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    809880 UNK HAKIM PROGRAMMABLE VALVE SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention