BEUDAMED
    FDA Adverse Event Death Summary report: N

    HAKIM VALVE INLINE UNIT (INTEGRAL CON)

    MDR report key: 7292343 · Received February 23, 2018

    Report

    Report Number
    1226348-2018-10178
    Event Type
    Death
    Date Received
    February 23, 2018
    Manufacturer
    CODMAN & SHURTLEFF, INC. / MEDOS S.A.
    Product Code
    JXG
    PMA / PMN Number
    K974739
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION HAS BEEN RECEIVED INDICATING THAT THE PATIENT EXPERIENCED NEUROLOGICAL DEFICITS RELATED TO THE EVENT. IT WAS ALSO REPORTED THAT THE DEVICE WOULD NOT BE AVAILABLE FOR EVALUATION. UPON REVIEW OF MANUFACTURING RECORDS, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    UPDATED UDI : (B)(4). COMPLAINT SAMPLE WAS NOT RETURNED TO CODMAN; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED. A REVIEW OF MANUFACTURING RECORDS FOUND NO DISCREPANCIES RELATED TO THE REPORTED ISSUE. THE CAUSE(S) OF THE DIFFICULTY REPORTED BY THE CUSTOMER COULD NOT BE DETERMINED. IF ADDITIONAL RELEVANT INFORMATION 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

    UPDATED INFORMATION : ADDITIONAL EVENT INFORMATION HAS BEEN PROVIDED BY THE INITIAL REPORTER. IT HAS BEEN REPORTED THAT THE PATIENT DIED SUBSEQUENT TO THE INITIALLY REPORTED ISSUE. NO CAUSE OF DEATH OR OTHER MEDICAL RECORDS HAVE BEEN PROVIDED. TO DATE, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, THE COMPLAINT WILL BE REOPENED AND A FOLLOW-UP REPORT WILL BE SUBMITTED. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Additional Manufacturer Narrative · 1

    (B)(4). UPON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    AS REPORTED BY THE OUS SALES REP, CHPV INLINE VALVE HAD UNEXPECTED SETTING CHANGES AFTER IMPLANTATION, THE PATIENT DEVELOPED SUBDURAL HEMATOMA WITH SYMPTOMS OF SYNCOPE AND SUBSEQUENTLY DIED. IT WAS REPORTED THAT THE PATIENT CONDITION HAD IMPROVED, AMBULATING WITH A WALKER, THEREFORE, THE VALVE PROGRAMMING WAS CHANGED FROM 110 MMHG TO 100 MMHG, ALTHOUGH THERE WAS NO X-RAY CONFIRMATION OF SETTING CHANGE. THIRTEEN DAYS AFTER THE PROGRAMMING CHANGE, THE PATIENT PRESENTED TO THE HOSPITAL, WITH SYNCOPE, AND WAS DIAGNOSED WITH SUBDURAL HEMATOMA. THE VALVE SETTING WAS NOTED TO BE AT 30 MMHG AT THIS TIME. THE PATIENT SUBSEQUENTLY DIED THE FOLLOWING DAY, AND THE VALVE WAS REMOVED POST MORTEM. NO MAGNETIC FIELD EXPOSURE OR TRAUMA TO VALVE WAS REPORTED.

    Description of Event or Problem · 1

    AS REPORTED BY THE OUS SALES REP, CHPV INLINE VALVES W/O SIPHONGUARD CHANGED THEIR SETTING AFTER PATIENTS LEFT THE HOSPITAL. THERE WERE NO REPORTS OF DELAY OR PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137119 HAKIM VALVE INLINE UNIT (INTEGRAL CON) SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC. / MEDOS S.A. 133046

    Patients

    Seq Age Sex Outcome Treatment
    1 Death