BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 5015512 · Received August 19, 2015

    Report

    Report Number
    3004209178-2015-16298
    Event Type
    Malfunction
    Date Received
    August 19, 2015
    Report Date
    July 27, 2015
    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
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8709, LOT# J11048R55, IMPLANTED: (B)(6) 2002, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) REGARDING A PATIENT RECEIVING INTRATHECAL COMPOUNDED BACLOFEN 3000 MCG/ML; 800 MCG/DAY VIA AN IMPLANTED PUMP. THE PATIENT EXPERIENCED A SUDDEN CHANGE IN THERAPY NOTED AS STIFFER, "A LITTLE CONFUSED" AND FOGGY. THERE WERE MULTIPLE MOTOR STALLS AND RECOVERIES. A MOTOR STALL OCCURRED (B)(6) 2015 13:38; MOTOR STALL (B)(6) 2015 05:53 WITH A MOTOR STALL RECOVERY (B)(6) 2015 05:29; MOTOR STALL (B)(6) 2015. THE PATIENT DID NOT RECENTLY HAVE MAGNETIC RESONANCE IMAGING (MRI). THE HCP WANTED TO SILENCE THE ALARMS AND PERMANENTLY DISABLE THE PUMP. THE DOSE WAS TURNED DOWN TO 149 MCG/DAY AND THE PATIENT WAS GIVEN ORAL BACLOFEN. PATIENT HISTORY INCLUDES INTRACTABLE SPASTICITY AND OTHER SPASTICITY. THE CAUSE OF THE EVENT, INTERVENTIONS, TROUBLESHOOTING/DIAGNOSTICS, AND FINAL PATIENT OUTCOME WERE NOT REPORTED. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    550143 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00052 YR