BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2823143 · Received November 7, 2012

    Report

    Report Number
    3004209178-2012-10009
    Event Type
    Injury
    Date Received
    November 7, 2012
    Date of Event
    October 9, 2012
    Report Date
    October 10, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 8709SC LOT# N177787007, IMPLANTED: 2008 (B)(6), PRODUCT TYPE CATHETER, (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A POCKET FILL OCCURRED. THE PATIENT STARTED TO ACT STRANGE APPROXIMATELY 1 HOUR AFTER HAVING THE PUMP REFILLED ON (B)(6) 2012. THE PATIENT'S FAMILY CALLED 911 AND THE PATIENT WAS TRANSPORTED VIA AMBULANCE TO EMERGENCY DEPARTMENT (ED). UPON ARRIVAL TO ED PATIENT WAS NOT RESPONSIVE. THE OTHER SYMPTOMS ASSOCIATED WITH THE OVERDOSE AND POCKET FILL WERE DECREASED RESPIRATORY RATE, DECREASED HEART RATE, SOMNOLENCE AND ALTERED MENTAL STATUS. THE ED HEALTHCARE PROVIDER (HCP) ADMINISTERED NARCAN AND THE PATIENT BECAME RESPONSIVE. THE PUMP MANAGEMENT HCP WAS CONTACTED AND THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT (ICU). THE PUMP WAS PROGRAMMED TO A MINIMUM RATE AT THAT TIME AND THE RESERVOIR VOLUME WAS CHECKED. THE EXPECTED RESIDUAL VOLUME WAS 39.5ML AND THE HCP ASPIRATED ONLY 3ML, THEREFORE, THE POCKET FILL WAS DETERMINED. AS OF (B)(6) 2012, THE PATIENT WAS ABLE TO BE ROUSED BUT WAS SLEEPY, AND WAS BEING TREATED MEDICALLY IN THE ICU. THE MEDICATIONS IN THE PUMP WERE INFUMORPH AND CLONIDINE. 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
    1 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00088 YR Hospitalization| R