BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2935376 · Received January 30, 2013

    Report

    Report Number
    3004209178-2013-01117
    Event Type
    Injury
    Date Received
    January 30, 2013
    Report Date
    January 7, 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
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP FOUND THAT THE PUMP WAS STALLED UPON RECEIPT. THE STALL OBSERVED UPON ARRIVAL RECOVERED BEFORE THE INTERNAL DECONTAMINATION PROCESS. THE PUMP STALLED AGAIN WHEN PERFORMING THE DISPENSE TESTING. RESIDUE WAS FOUND ON THE UPPER SHAFT OF THE ROTOR MAGNET AND GEAR TWO AND THE CORRESPONDING JEWELS. PUMP MOTOR GEAR TRAIN ANOMALY CORROSION AND-OR WEAR AND-OR LUBRICATION WAS NOTED.

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A MOTOR STALL WAS REPORTED. THE STALL WAS REPORTED TO HAVE NEVER RECOVERED. THE PATIENT WAS REPORTED TO HAVE EXPERIENCED WITHDRAWAL SYMPTOMS, AND THE PATIENT WENT TO THE ER. THE PATIENT'S STATUS WAS NOTED TO BE "OK," ALIVE, AND WITHOUT INJURY. THE PATIENT WAS NOTED TO BE RECEIVING EFFECTIVE THERAPY. THE MEDICATION USED WITHIN THE SYSTEM WAS MORPHINE (PURE) 10 MG/ML. NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF THIS SUBMISSION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PUMP ACOUSTIC ALARM HAD SOUNDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41010 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR Required Intervention