BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3202619 · Received July 2, 2013

    Report

    Report Number
    3004209178-2013-01466
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 5, 2012
    Report Date
    June 5, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8840, SERIAL# UNKNOWN, PRODUCT TYPE PROGRAMMER, PHYSICIAN; PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROGRAMMER TURNED OFF DURING INTERROGATION OF THE PUMP. WHEN THE HEALTH CARE PROVIDER (HCP) INTERROGATED THE PUMP WITH A SECOND PROGRAMMER THE PUMP WAS IN ¿STOPPED MODE¿ DUE TO THE INCOMPLETE TELEMETRY. THE HCP REPROGRAMED THE PATIENT¿S SETTINGS AND THE PUMP WAS UPDATED. THE ISSUE WAS RESOLVED. THERE WERE NO SYMPTOMS REPORTED. THE DEVICE SYSTEM WAS BEING USED TO DELIVER COMPOUNDED BACLOFEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302612 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR