BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2863924 · Received December 10, 2012

    Report

    Report Number
    3004209178-2012-11366
    Event Type
    Injury
    Date Received
    December 10, 2012
    Report Date
    November 9, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709 SERIAL# (B)(4), IMPLANTED: 2003 (B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH AN UNKNOWN CAUSE. THE REPORTER STATED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2012 WITH POSSIBLE NARCOTIZATION OR SEPSIS, BUT THEY ARE NOT CERTAIN WHAT THE EXACT ISSUE WAS AND THERE WERE NO SPECIFIC SYMPTOMS PROVIDED. THE REPORTER STATED THAT IT WAS CONFIRMED THAT ALL PUMP PROGRAMMING WAS CORRECT AND THE EVENT LOGS WERE NORMAL. THE REPORTER WAS UNSURE IF THE PATIENT WAS ON ANY FORM OF NARCOTICS, HOWEVER, THERE WAS NO NARCOTIC IN THE PUMP. THE HEALTHCARE PROVIDER WAS UNSURE "WHAT'S GOING ON" AND THEY ARE TRYING TO RULE OUT ALL THINGS. THE MEDICATION IN THE PUMP WAS BACLOFEN. THE REPORTER LATER UPDATED THAT "THERE WAS NOTHING SIGNIFICANT TO REPORT" AND THE CAUSE OF THE EVENT WAS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization