BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAKIM VALVE INLINE UNIT (INTEGRAL CON)

    MDR report key: 1203444 · Received October 17, 2008

    Report

    Report Number
    1226348-2008-00272
    Event Type
    Malfunction
    Date Received
    October 17, 2008
    Date of Event
    August 27, 2008
    Manufacturer
    CODMAN & SHURTLEFF, INC./MEDOS S.A.
    Product Code
    JXG
    PMA / PMN Number
    K974739
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT HAS BEEN COMMUNICATED THAT THE DEVICE AND/OR LOT INFO IS NOT AVAILABLE FOR EVAL. WITHOUT THE DEVICE AND/OR LOT INFO, IT IS NOT POSSIBLE FOR CODMAN TO CONDUCT A PROPER INVESTIGATION. IF AT SOME POINT THE DEVICE AND/OR LOT INFO DOES BECOMES AVAILABLE, THIS COMPLAINT WILL BE RE-OPENED, EVALUATED AND A FOLLOW-UP REPORT WILL BE FILED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED CLOSED.

    Description of Event or Problem · 1

    AFFILIATE REPORTED THAT IN 2008, THE DEVICE WAS IMPLANTED INTO THE PATIENT FOR PRESSURE SETTINGS OF 80MMH2O. AT ABOUT 7 MONTHS LATER, THE PATIENT SHOWED ENLARGEMENT OF THE VENTRICLE. THE DOCTOR TRIED TO CHANGE THE PRESSURE SETTINGS FROM 80MM TO 40MM, BUT IT WAS SET AS 180MM. AT APPROX 2 WEEKS LATER, THE DOCTOR STARTED TO FLASH THE VALVE TO PUSH IT, BUT THE PATIENT'S CONDITION DID NOT RECOVER. AT ABOUT SIX DAYS LATER: THE DOCTOR TRIED TO CHANGE THE PRESSURE SETTINGS FROM 180MM TO 40MM. SINCE IT WORKED, THE DEVICE DID NOT GET REPLACED. THE DOCTOR COMMENTED ON AUG 27TH, HE FOUND MANY PIECES OF TISSUE IN THE VALVE. HE FELT THIS MAY HAVE PREVENTED THE CAM FROM TURNING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR