BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3951032 · Received July 22, 2014

    Report

    Report Number
    3004209178-2014-13376
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Report Date
    June 30, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8596, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: CATHETER; PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN MRI ON (B)(6) 2014 AND DID NOT HAVE THE PUMP CHECKED AFTER THE MRI. THE MANUFACTURER'S REPRESENTATIVE INTERROGATED THE PUMP TWICE DURING THE CALL AND A MOTOR STALL RECOVERY WAS NOTED WITH THE DATE AND TIME OF THE PHONE CALL. TELEMETRY MODE/STATE WAS SUSPECTED. THE PATIENT REPORTEDLY HAD NO SYMPTOMS AND DID NOT HEAR THE ALARM. THE ISSUE HAD REPORTEDLY BEEN RESOLVED. THE PATIENT'S PUMP WAS INTENDED TO INFUSE DILAUDID. IT WAS LATER REPORTED THAT THE MRI WAS NOT PERFORMED BECAUSE OF THE DEVICE. IT WAS UNCLEAR IF THIS WAS REFERRING TO A DIFFERENT MRI. THE PUMP WAS REPORTEDLY WORKING PROPERLY AND THE PATIENT WAS DOING FINE AT THE TIME OF REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428245 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR