BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 4987869 · Received August 10, 2015

    Report

    Report Number
    3004209178-2015-15690
    Event Type
    Malfunction
    Date Received
    August 10, 2015
    Date of Event
    March 16, 2015
    Report Date
    July 17, 2015
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL DEVICES: PRODUCT ID: 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A CLINICAL STUDY REGARDING A PATIENT FENTANYL (200 MCG/ML AT 33.05 MCG/DAY), CLONIDINE (500 MCG/ML AT 82.62 MCG/DAY), AND COMPOUNDED BACLOFEN (400MCG/ML AT 66.09 MCG/DAY) VIA AN IMPLANTABLE INFUSION PUMP. THE INDICATION FOR USE WAS NOTED AS INTRACTABLE SPASTICITY. IT WAS REPORTED A PUMP MOTOR STALL WITH RECOVERY OCCURRED. THE PATIENT EXPERIENCED NO SYMPTOMS. THE SEVERITY OF THE EVENT WAS NOTED AS MILD. THE PATIENT UNDERWENT AN MRI ON (B)(6) 2015. THE DEVICE WAS INTERROGATED ON (B)(6) 2015 AND THE MOTOR STALLS WERE FOUND. A MOTOR STALL OCCURRED ON (B)(6) 2015 WITH A RECOVERY ON THE SAME DATE. A MOTOR STALL OCCURRED ON (B)(6) 2015 WITH A RECOVERY ON THE SAME DATE. A MOTOR STALL OCCURRED ON (B)(6) 2015 WITH A RECOVERY ON THE SAME DATE. THE CAUSE OF THE MOTOR STALLS WAS UNKNOWN. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522050 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR