BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2970336 · Received February 20, 2013

    Report

    Report Number
    3004209178-2013-02909
    Event Type
    Injury
    Date Received
    February 20, 2013
    Report Date
    January 28, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2000, EXPLANTED: (B)(6) 2012, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD TO HAVE THEIR PUMP REMOVED. ON (B)(6) 2012, THE PATIENT'S PUMP HAD COME OUT THROUGH THEIR INCISION. IT WAS REPORTED, "I WAS TOLD IT COULD OF POSSIBLY BEEN DUE TO THE STEROIDS I HAD BEEN ON TWO MONTHS PRIOR." IT WAS REPORTED, "IT HAS BEEN FOUR WEEKS AND I AM STILL SUFFERING FROM WITHDRAWALS. I HAVE HAD TO BE PUT ON HIGH BLOOD PRESSURE MEDICINE IN THE LAST THREE WEEKS." IT WAS REPORTED THE PATIENT WAS SEVERELY WEAK AND VERY ANXIOUS. IT WAS REPORTED, "I WAS TOLD I HAD TO WAIT TO HEAR FROM THE INFECTIOUS PEOPLE BEFORE I CAN HAVE A NEW PUMP PUT BACK IN." IT WAS LATER REPORTED AN INFECTION HAD OCCURRED. THE PUMP WAS EXPLANTED. THE PATIENT EXPERIENCED REDNESS, DEHISCENCE AND WAS HOSPITALIZED. THE OUTCOME TO THE PATIENT WAS A NON-SERIOUS INJURY/ILLNESS. IT WAS LATER REPORTED, "ACCORDING TO THE LAB REPORT THE PUMP ITSELF STATED IT WAS NEGATIVE OF ANY BACTERIA. MY DOCTORS SEEM TO THINK IT WAS BECAUSE OF THE PREDNISONE I HAD BEEN ON THE 2 MONTHS PRIOR. I AM PLANNING ON HAVING ANOTHER ONE PUT IN ONCE I AM OVER WITH THE WITHDRAWALS FROM THE SUDDEN REMOVAL." IT WAS NOTED THE PUMP DID HELP WITH THE PATIENT'S PAIN ONCE IT WAS ADJUSTED TO THE PROPER LEVELS AND NOW WITH THE PATIENT MANAGEMENT DEVICE IT WORKED EVEN BETTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73601 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR Hospitalization| R