BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3170169 · Received June 14, 2013

    Report

    Report Number
    3004209178-2013-10380
    Event Type
    Injury
    Date Received
    June 14, 2013
    Report Date
    May 22, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS ALSO REPORTED THAT THE PATIENT PUMP AT REFILLS WERE USUALLY ABOUT 3 CUBIC CENTIMETERS (CC) OFF AT EACH REFILLS WERE THE ACTUAL RESIDUAL WERE MORE THAN WHAT WAS EXPECTED. IT WAS NOTED THAT THE ACTUAL VOLUME REMAINING WAS 3.3CC IN (B)(6) AND IT WAS ALSO NOTED THAT A RANGE OF 2CC TO 4CC REMAINS WHEN CLOSE TO 1CC WAS EXPECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT MISSED A REFILL DUE TO THE PATIENT WAS IN THE HOSPITAL FOR REASONS UNRELATED TO THE PUMP. IT WAS REPORTED THAT THE PATIENT LAST REFILL WAS ON (B)(6) 2013 AND THE PATIENT MISSED SCHEDULED REFILL WAS ON (B)(6) 2013. IT WAS NOTED THAT PATIENT ¿HAD SOME PROBLEMS¿ AFTER MISSED REFILL BUT THE PATIENT WAS MANAGED WITH ORAL BACLOFEN AND SEEMED TO BE DOING WELL. THE DEVICE SYSTEM WAS USED TO DELIVER BACLOFEN. IT WAS LATER REPORTED THAT THE PATIENT EXPERIENCED WITHDRAWAL SYMPTOMS. THE PUMP LOGS INDICATED THAT THE PUMP WENT EMPTY ON (B)(6) 2013. IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR FEVER AND AN INFECTION A FEW DAYS AFTER MISSED REFILL. IT WAS UNCLEAR IF THE PATIENT HAD OTHER INFECTION OR ONLY HAD ¿AN URINARY TRACT INFECTION OR SOMETHING ELSE¿. IT WAS REPORTED THAT THE PATIENT EXPERIENCED ¿DANCING AND JERKING¿ WHILE IN THE HOSPITAL. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270623 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O