BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3201632 · Received July 2, 2013

    Report

    Report Number
    3004209178-2013-03426
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    January 13, 2012
    Report Date
    January 13, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8731SC, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ALARMED WAS HEARD, BUT HAD NOT BEEN CHECKED BY TELEMETRY. IT WAS A NON-CRITICAL ALARM. THE PATIENT WAS SCHEDULED FOR A REFILL (B)(6) 2012, BUT HAD TO RESCHEDULE TO (B)(6) 2012. THE ALARM WAS HEARD (B)(6) 2012. THE DEVICE SYSTEM WAS USED TO DELIVER BACLOFEN. 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
    303269 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00024 YR