BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3202702 · Received July 2, 2013

    Report

    Report Number
    3004209178-2013-04771
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 14, 2012
    Report Date
    June 14, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8590-1, LOT# N158078, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 8731SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: CATHETER. PRODUCT ID: 8835, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A MOTOR STALL AFTER AN MAGNETIC RESONANCE IMAGE (MRI). IT WAS STATED THAT THE HEALTHCARE PROVIDER (HCP) PERFORMED A REFILL AND THEN THE PATIENT WENT TO MRI. IT WAS STATED THAT THE DEVICE WAS INTERROGATED APPROXIMATELY 10 MINUTES AFTER THE MRI AND THE MOTOR STALL WAS CONFIRMED IN THE EVENT LOGS. NO MOTOR RECOVERY HAD BEEN REPORTED. IT WAS STATED THAT THE MRI WAS FOR "OTHER MEDICAL REASONS." THE PATIENT LEFT BEFORE EVENT WAS REPORTED, SO THE PUMP COULD NOT BE INTERROGATED ANY FURTHER TO CONFIRM RECOVERY. THE PATIENT OUTCOME WAS UNKNOWN. THE PUMP WAS USED TO INFUSE FENTANYL, CLONIDINE, AND BUPIVACAINE (MARCAINE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300894 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR