BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3431410 · Received October 28, 2013

    Report

    Report Number
    3004209178-2013-19732
    Event Type
    Malfunction
    Date Received
    October 28, 2013
    Date of Event
    October 6, 2013
    Report Date
    October 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
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004, PRODUCT TYPE: CATHETER; PRODUCT ID 8575, LOT# N203321, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TELEMETRY CONFIRMED A CRITICAL ALARM WAS OCCURRING. THE LOGS SHOWED SAFE STATE ( AND NO OTHER EVENTS IN THE LOGS) OCCURRED (B)(6) 2013 AT 10:03. THE PATIENT WAS SWEATY, AGITATED AND HIGH PULSE (120-150) AND BLOOD PRESSURE. PER THE HCP THE PATIENT¿S FAMILY HEARD THE ALARM THE MORNING OF THE REPORT. THE HCP PROGRAMMED THE PUMP OUT OF SAFE STATE TO SIMPLE CONTINUOUS AND UPDATE THE PUMP SUCCESSFULLY. THE PUMP WAS USED TO DELIVER BACLOFEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    552337 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00017 YR