BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4171040 · Received October 14, 2014

    Report

    Report Number
    3004209178-2014-19675
    Event Type
    Injury
    Date Received
    October 14, 2014
    Report Date
    September 22, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT¿S PUMP WAS IMPLANTED ON (B)(6) 2014 AND THE PATIENT¿S CONDITION HAD CHANGED ON THE MORNING OF THIS REPORT; HOWEVER THE PATIENT WAS DOING WELL THIS MORNING. IT WAS NOTED AN OVERDOSE WAS REPORTED AND THE PATIENT WAS FLACCID IN THE LOWER EXTREMITIES. THE HEALTHCARE PROVIDER (HCP) DECREASED THE DOSE ON THE DATE OF THIS REPORT TO 30MCG/DAY. THE PATIENT¿S PREVIOUS DOSE WAS 47MCG/DAY WITH A CONCENTRATION OF 500MCG/ML. IT WAS FURTHER REPORTED THE CAUSE OF THE ISSUE WAS LATER DETERMINED TO HAVE BEEN DEEP VEIN THROMBOSIS (DVT) AND BILATERAL PULMONARY EMBOLISM (PE). THE PUMP WAS TURNED DOWN TO 24MCG/DAY WHILE A WORKUP ENSUED. IT WAS NOTED THE ISSUE HAD BEEN RESOLVED AND THE PATIENT ¿REPORTEDLY IMPROVED.¿ THE PUMP WAS BEING USED TO DELIVER BACLOFEN. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650762 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR Other