BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK HAKIM

    MDR report key: 7048899 · Received November 21, 2017

    Report

    Report Number
    1226348-2017-10865
    Event Type
    Injury
    Date Received
    November 21, 2017
    Date of Event
    May 6, 2010
    Product Code
    JXG
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UDI: UNKNOWN PRODUCT CODE. IT IS NOT CLEAR AT THIS POINT IF THE DEVICE AND/OR LOT INFORMATION IS AVAILABLE. WITHOUT THE DEVICE AND/OR LOT INFORMATION, IT IS NOT POSSIBLE FOR CODMAN TO CONDUCT A PROPER INVESTIGATION. IF THE DEVICE IS RETURNED, THE COMPLAINT WILL BE INVESTIGATED AND A FOLLOW UP REPORT WILL BE FILED. IF LOT INFORMATION DOES BECOMES AVAILABLE AND IF THE RECORD REVIEW INDICATES THAT THERE WAS A NON-CONFORMITY, A FOLLOW UP REPORT WILL BE FILED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME, THIS COMPLAINT IS CLOSED. DEVICE NOT AVAILABLE.

    Description of Event or Problem · 1

    IN THE LITERATURE ARTICLE ¿SYRINGOMYELIA WITH QUADRIPARESIS IN CSF SHUNT MALFUNCTION: A CASE ILLUSTRATION¿ PUBLISHED CHILDS NERV SYST (2010) 26:1229¿1231, DOI 10.1007/S00381-010-1165-3, IT WAS REPORTED THAT THIS (B)(6) YEAR-OLD MALE PATIENT HAD TREATMENT COMPLICATIONS AND DEVICE REVISION SECONDARY TO BLOCKAGE APPROXIMATELY 16 YEARS AFTER HAKIM VALVE IMPLANTATION. PER THE ARTICLE: ¿BACKGROUND SHUNT MALFUNCTION TYPICALLY PRESENTS WITH HEADACHES, VOMITING, AND IMPAIRED CONSCIOUSNESS. PARAPARESIS HAS BEEN RARELY REPORTED AS THE INITIAL MANIFESTATION OF VALVE DYSFUNCTION. CASE ILLUSTRATION A (B)(6)-YEAR-OLD BOY WAS ADMITTED WITH INVALIDATING QUADRIPARESIS THAT AFTER NEUROIMAGING EVALUATION WAS FOUND TO BE PRODUCED BY COMMUNICATING SYRINGOMYELIA ATTRIBUTED TO SHUNT MALFUNCTION. DISCUSSION AND CONCLUSION PERSISTENCE OF THE CENTRAL CANAL IN ASSOCIATION WITH COMMUNICATING HYDROCEPHALUS MAY LEAD TO THE DEVELOPMENT OF COMMUNICATING SYRINGOMYELIA. IN THIS CONTEXT, INSUFFICIENT DRAINAGE OF CSF PRODUCED BY SHUNT DYSFUNCTION MAY EVOLVE EXCLUSIVELY WITH SYMPTOMS AND SIGNS OF SPINAL CORD INVOLVEMENT IN THE ABSENCE OF THE USUAL CEREBRAL MANIFESTATIONS RELATED TO SHUNT FAILURE.¿ IT WAS REPORTED THAT DEVICE REVISION WAS SUCCESSFULLY COMPLETED WITH RETURN TO BASELINE NEUROLOGIC STATUS FOR THE PATIENT. 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
    829967 UNK HAKIM SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention