BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3800646 · Received May 8, 2014

    Report

    Report Number
    3004209178-2014-08751
    Event Type
    Injury
    Date Received
    May 8, 2014
    Report Date
    April 15, 2014
    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
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: 2012 (B)(6); PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTED TO INCLUDE ADVERSE EVENT AS WELL AS PRODUCT PROBLEM.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP WAS ALARMING. TELEMETRY CONFIRMED A CRITICAL ALARM DUE TO ¿STOPPED PUMP PERIOD MAY EXCEED TUBE SET¿. ON (B)(6) 2014, THE HCP (HEALTHCARE PROVIDER) TURNED OFF THE PUMP AND IT HAD BEEN ALARMING FOR ABOUT A WEEK. THE PATIENT FOUND THE PUMP TO BE VERY BENEFICIAL, BUT ¿THE PUMP HURTS¿ SO THEY DECIDED TO REMOVE IT. THE SURGEON WANTED THE PATIENT TO WAIT A MONTH BEFORE MAKING THE DECISION FINAL. THE DEVICE SYSTEM WAS DELIVERING BACLOFEN.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED BY THE HEALTHCARE PROVIDER (HCP) STATING THE PUMP ITSELF CAUSED PAIN AND PERHAPS BY MOVING AGAINST THE RIB CAGE. IT WAS NOTED THAT THE PUMP WAS TURNED OFF AT PATIENT¿S REQUEST AND FILLED WITH SALINE UNTIL SURGEON REVISES IT. IT WAS REPORTED THAT THE PATIENT LIKED THE INTRATHECAL BACLOFEN THERAPY; THEY JUST DID NOT LIKE THE PUMP ITSELF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279466 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention