BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PROGRAMMABLE VALVE WITHOUT PRECHAMBER

    MDR report key: 3893471 · Received June 25, 2014

    Report

    Report Number
    1226348-2014-11744
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    May 28, 2014
    Manufacturer
    CODMAN & SHURTLEFF
    Product Code
    JXG
    PMA / PMN Number
    PK974739
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED. DEVICE IS UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE LOT AND EXPIRATION ARE ADDITIONAL INFORMATION. THE VALVE WAS RETURNED FOR EVALUATION. THE INVESTIGATION OF THE RETURNED VALVE DID CONFIRM A PROBLEM. THE LOT NUMBER P1721, SERIAL NUMBER WAS (B)(4), PRODUCT CODE 82-3101. -VISUAL EXAMINATION OF THE VALVE REVEALED THAT THE VALVE CASING WAS CRACKED AND SITTING ON THE CAM MECHANISM. THEREFORE; THE CAM POSITION/PRESSURE COULD NOT BE DETERMINED. THE VALVE WAS DISMANTLED AND WAS EXAMINED UNDER MICROSCOPE AT APPROPRIATE MAGNIFICATION: IT WAS NOTED THAT THE VALVE CASING WAS CRACKED; THIS IS DUE TO THE VALVE RECEIVING A HARD KNOCK. THE CAM MECHANISM WAS ALSO DAMAGED DUE TO THE HARD KNOCK. REVIEW OF THE HISTORY DEVICE RECORDS CONFIRMED THE VALVE PRODUCT CODE 82-3101 WITH LOT P1721 CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK ON THE 25TH JANUARY 1999. THE ROOT CAUSE OF THE CRACKED CASING IS DUE TO THE VALVE RECEIVING A HARD KNOCK. NO CORRECTIVE ACTION IS NEEDED BASED ON THE RESULTS OF THE EVALUATION. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME, THIS COMPLAINT IS CONSIDERED CLOSED.

    Description of Event or Problem · 1

    THE DEVICE WAS IMPLANTED VIA V-P SHUNT IN 1999, TO THE PATIENT WITH INTRACEREBRAL HEMORRHAGE. THE PATIENT IS (B)(6) OLD MALE. DOI AND THE INITIAL SETTING PRESSURE WERE UNKNOWN. THE PATIENT HAD POSTURE HYPOTENSION AND VISITED AT THE HOSPITAL ON (B)(6) 2014. IT IS NOTED THE SETTING PRESSURE COULD NOT BE CHANGED WITH VPV. THE CONTRAST RADIOGRAPHY WAS CONDUCTED AND THE ABDOMINAL CATHETER SEEMED TO BE DISLODGED ALTHOUGH FLUID FLOWED THROUGH THE DEVICE. THEREFORE, THE REVISION SURGERY WAS CONDUCTED ON (B)(6) 2014 AND THE DEVICE WAS REPLACED WITH ANOTHER DEVICE (823142). THE SETTING PRESSURE OF THE REMOVED VALVE AND THE REPLACED VALVE WERE UNKNOWN. THE CUSTOMER REQUESTS TO OBTAIN INFORMATION FOR THE RESULT OF PRESSURE TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371957 HAKIM PROGRAMMABLE VALVE WITHOUT PRECHAMBER SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF P1721

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Required Intervention