BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2962261 · Received February 14, 2013

    Report

    Report Number
    3004209178-2013-02664
    Event Type
    Injury
    Date Received
    February 14, 2013
    Report Date
    January 17, 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
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    ALL PREVIOUSLY REPORTED DEVICE CODES WILL BE UPDATED/CORRECTED TO THE FOLLOWING FOR THIS EVENT: (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8731SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2012. PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: IT WAS REPORTED THAT THE PATIENT WAS OVERDOSED IN (B)(6) 2013. THE PATIENT EXPERIENCED A RETURN OF PATIENT SYMPTOMS. IT WAS REPORTED THAT THE ¿PUMP WAS STUFFED UP AND THEY OD'ED ME WHEN THEY WENT TO INJECT, TO SEE WHAT WAS WRONG WITH THE PUMP.¿ THE PATIENT EXPERIENCED NUMBNESS FROM THE NECK DOWN. THE PATIENT ¿ADORED¿ HER PERSONAL THERAPY MANAGER (PTM). THE DEVICES WERE ¿ABSOLUTELY FABULOUS.¿ THE PATIENT HAD BEEN IN A WHEELCHAIR FOR A LONG TIME AND HAD RHEUMATOID ARTHRITIS AND SYSTEMIC ¿LUPUS/MS¿ AND THE PUMP GAVE THE PATIENT ¿HER LIFE BACK¿ FOR THE LAST TWO YEARS. THE PATIENT RECENTLY STARTED WITH A NEW HEALTHCARE PROVIDER (HCP) AND BEGAN TO EXPERIENCE PROBLEMS. THE PATIENT HAD SURGERY FOR ¿THE LINES BEING BENT, STOPPED UP OR WHATEVER.¿ FOLLOWING SURGERY THE PATIENT WAS TAKEN OFF OF THE PTM AND WAS GIVEN ORAL PERCOCET. THE PATIENT HAD HEPATITIS C DUE TO OPIOID ORAL PAIN MEDICATION. THE PATIENT TOLERANCE WAS ¿EXTREMELY HIGH¿ SO THE ORAL MEDICATIONS DO NOT DO HER ¿ANY GOOD.¿ THIS WAS THE REASON THAT THE PUMP WAS PUT IN. THE PATIENT¿S (B)(6) WAS IN REMISSION WITH THE USE OF THE PTM, BUT IT WAS NOW BOTHERING HER AGAIN AND HAD BEEN BACK FOR THREE MONTHS. THE PERCOCET WAS NOT LASTING OR WORKING FOR THE PATIENT, AND SHE HAD TO TAKE MORE THAN REQUIRED. THE HCP PLANNED TO GIVE THE PATIENT THE PTM BACK WHEN THEY WERE UP TO THERAPEUTIC LEVELS OF (B)(46..

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A REVISION SURGERY DUE TO A CATHETER KINK. THE PATIENT HAD PRESENTED WITH INCREASED PAIN DESPITE THE INCREASE OF MEDICATION AND BOLUSES. DURING A CATHETER ACCESS PORT CONTRAST STUDY, THE KINK WAS FOUND. A FEW DAYS LATER, A SIGNIFICANT PORTION OF REDUNDANT CATHETER WAS REMOVED. IT WAS NOTED THAT THE EVENT WAS RESOLVED WITHOUT SEQUELA. LATER, IT WAS REPORTED THAT THERE HAD ALSO BEEN CATHETER TIP FIBROSIS AS IT WASN'T POSSIBLE TO ASPIRATE THE CATHETER SIDE-PORT. THE DRUGS USED IN THIS SYSTEM WERE FENTANYL AND BUPIVACAINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64983 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention