BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2041388 · Received March 24, 2011

    Report

    Report Number
    3004209178-2011-02257
    Event Type
    Malfunction
    Date Received
    March 24, 2011
    Date of Event
    January 11, 2010
    Report Date
    March 3, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    SINCE IMPLANT, THE PT NEVER HAD THERAPEUTIC EFFECT. THERE WERE NO PUMP ALARMS; THE PUMP PROGRAMMING WAS CORRECT; AND THERE HAD BEEN NO VOLUME DISCREPANCIES. A DYE STUDY WAS DONE AND NO PROBLEM WAS FOUND. A (B)(6) STUDY WAS PERFORMED VIA CT SCAN AND THE IMAGING WAS QUESTIONABLE. THE PHYSICIAN CONSULTED WITH ANOTHER PHYSICIAN AND A SUBDURAL CATHETER WAS NOTED. THE DEVICE SYSTEM WAS USED TO DELIVER LIORESAL 2000 MCG/ML AT 450 MCG/DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR IMPLANTED:| ACCESSORY: MODEL 8590-1, LOT # N231078| IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8709SC, LOT # N222432002| EXPLANTED: