BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3145618 · Received June 4, 2013

    Report

    Report Number
    3004209178-2013-08613
    Event Type
    Injury
    Date Received
    June 4, 2013
    Report Date
    May 13, 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
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP FOUND AN ANOMALY WITH THE MOTOR; THE COIL SHORTED TO CASE.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4).

    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 AND NEVER RECOVERED. THE PATIENT EXPERIENCED UNDERDOSE SYMPTOMS AND REQUIRED INTRA VENOUS INFUSION WITH MORPHINE. THE DEVICE REMAINED IMPLANTED- OUT OF SERVICE. THE DEVICE SYSTEM WAS USED TO INFUSE MORPHINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT ALREADY GOT A NEW PUMP. THE PATIENT¿S STATUS WAS ¿OK NOW, DUE TO PUMP REPLACEMENT¿.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247118 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention