BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3161855 · Received June 11, 2013

    Report

    Report Number
    3004209178-2013-10128
    Event Type
    Injury
    Date Received
    June 11, 2013
    Report Date
    May 14, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8711, LOT# J10855R33, IMPLANTED: (B)(6) 2001. PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED WITHDRAWAL PRIOR TO THE PUMP REFILL. THE PATIENT MISSED THE REFILL ON (B)(6) 2013 AND THE VOLUME IN THE PUMP WAS BELOW THE RECOMMENDED VOLUME TO MAINTAIN ADEQUATE INFUSION. IT WAS BELIEVED THAT THE PUMP WOULD HAVE BEEN EMPTY ON (B)(6) 2013. ON (B)(6) 2013 THE PATIENT WAS SEEN FOR DRUG WITHDRAWAL AND HOSPITALIZED IN THE INTENSIVE CARE UNIT. AS OF THE DATE OF THIS REPORT THE PATIENT WAS STILL HOSPITALIZED. THE PUMP WAS REFILLED ON (B)(6) 2013. THE DEVICE SYSTEM WAS USED TO DELIVER MORPHINE AND CLONIDINE. IT WAS LATER REPORTED THAT THE PATIENT¿S WIFE INDICATED THAT THEY NEVER HEARD THE ALARM. IT WAS LATER REPORTED THAT THE DAY AFTER THE PUMP WAS REFILLED THE PATIENT WAS FEELING MUCH BETTER. THE PATIENT HAD BEEN ADMITTED TO THE ICU DUE TO AN ALTERED LEVEL OF CONSCIOUSNESS AND HYPERTENSION. THE LOW RESERVOIR ALARM OCCURRED ON (B)(6) 2013 AND THE EMPTY PUMP RESERVOIR OCCURRED ON (B)(6) 2013. IT WAS NOTED THAT THE PATIENT WAS ALSO RECEIVING LORTAB TWICE DAILY AND WAS INSTRUCTED BY THE PHYSICIAN TO TAKE AN EXTRA DOSE TO HELP GET THROUGH WITHDRAWAL. IT WAS LATER REPORTED THAT THE PATIENT EXPERIENCED HIGH BLOOD PRESSURE, DECREASED LEVEL OF CONSCIOUSNESS AND INCREASED PAIN. THE PUMP WAS INTERROGATED AND THE CRITICAL ALARM WAS CHANGED FROM ONE HOUR TO 10 MINUTES. THE PATIENT WAS DOING WELL AND HIS PAIN WAS WELL CONTROLLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262109 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R