BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3162228 · Received June 11, 2013

    Report

    Report Number
    3004209178-2013-10133
    Event Type
    Injury
    Date Received
    June 11, 2013
    Report Date
    May 17, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. PRODUCT TYPE: CATHETER: PRODUCT ID 8840, SERIAL# UNKNOWN. PRODUCT TYPE: PROGRAMMER, PHYSICIAN. (B)(4).

    Description of Event or Problem · 1

    A HEALTHCARE PROVIDER (HCP) REPORTED THAT THEY WERE ¿CURRENTLY IN A PROCEDURE¿ FOR A PATIENT THAT CAME IN ON AN URGENT BASIS AFTER HAVING A REFILL ON (B)(6) 2013. NO ADJUSTMENTS WERE MADE AT THE REFILL. AT THE TIME OF THE REPORT, THE PATIENT COMPLAINED OF SHORTNESS OF BREATH, FEELINGS OF WEAKNESS, NAUSEA, AND ¿NOT FEELING GOOD¿. THE HCP WAS GOING TO PERFORM AN INFECTIOUS WORKUP. THE PUMP WAS INTERROGATED AND NOTHING WAS ABNORMAL. THE HCP WAS ¿LEANING MORE TOWARD INFECTION¿ BECAUSE THE PATIENT¿S SPASTICITY HAD GREATLY INCREASED AND THEY WERE IN SEVERE PAIN THROUGHOUT THEIR BODY. THE PATIENT¿S VITALS WERE STABLE LAST NIGHT WHEN SHE HAD CALLED EMERGENCY MEDICAL SERVICES. THE PATIENT WAS NOT HOSPITALIZED. RESIDUAL VOLUMES WERE NOT CHECKED. IT WAS CONFIRMED THAT THE PATIENT WAS FILLED WITH 2000 MCG/ML LIORESAL WHICH WAS PREVIOUSLY IN THE PUMP. THE PATIENT¿S VITALS WERE NOTED TO BE STABLE IN THE OFFICE AS OF THE DATE OF THE REPORT. THE PATIENT WAS NOTED TO FEEL PRETTY SICK AND LOOK PRETTY SICK. THEY DID NOT HAVE LABORED BREATHING. THE HCP DID NOT SUSPECT A POCKET FILL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262052 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00057 YR Other