BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4133758 · Received October 1, 2014

    Report

    Report Number
    3004209178-2014-18139
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    September 5, 2014
    Report Date
    September 9, 2014
    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
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8835, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 8709SC, SERIAL # (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED AN ALARM WAS HEARD WITH TELEMETRY NOT YET PERFORMED. THE PATIENT HAD BEEN LOCATED IN (B)(6) AND HAD A PAIN MANAGEMENT DOCTOR WHO FILLED THE PUMP FROM TIME TO TIME (THOUGHT TO BE A 6 MONTH INTERVAL). THE PATIENT WAS LOCATED IN (B)(6) AND AT THE TIME WAS IN (B)(6). THE PATIENT WOKE UP IN THE MORNING AND WAS REAL CLOSE TO RUNNING OUT, WITH THE ALARM HAVING GONE OFF ON (B)(6) 2014. IT WAS REPORTED THE ALARM WAS NOT TWO BELLS OR A REPETITIVE RINGING, BUT ONLY ONE BEEP. THE PATIENT WOKE UP IN THE MORNING SHAKING EVERY PART OF HIS BODY LIKE A SEIZURE. THE PATIENT WAS EXHIBITING THINGS LIKE ACHING EVERYWHERE AND FLU-LIKE SYMPTOMS. THE PATIENT WAS NOT THOUGHT TO BE RUNNING A FEVER OR ¿ANYTHING LIKE THAT.¿ THE PATIENT¿S HEALTH CARE PROVIDER IN LITTLE ROCK PRESCRIBED A PATCH. THE PATIENT WAS SEARCHING FOR A PHYSICIAN. IT WAS THEN REPORTED THE PATIENT WAS ACHING AND IT WAS PAINFUL, BUT HE SEEMED TO BE DOING MUCH BETTER THAN BEFORE. THE PATIENT WAS SHAKING UNCONTROLLABLY AND WAS NOW RESTING, STAYED IMMOBILE, AND WAS TURNING SOME. THE PATIENT HAD AN APPOINTMENT ON (B)(6) 2014 WITH THE HEALTH CARE PROVIDER (HCP) TO GET A REFILL. THERE WAS A LONG-TERM PLAN FOR GETTING THE PATIENT¿S BACK FIXED SURGICALLY AND THAT MAY HAVE BEEN ABLE TO ADDRESS SOME OF THE PATIENT¿S NEEDS. THE SYSTEM WAS BEING USED TO DELIVER HYDROMORPHONE. NO PATIENT OUTCOME WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610928 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00041 YR Other