BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3202832 · Received July 2, 2013

    Report

    Report Number
    3004209178-2013-11234
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Report Date
    June 10, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT¿S PUMP APPEARED TO HAVE STOPPED DELIVERING THERAPY. THE REPORTER DID NOT KNOW ADDITIONAL INFORMATION. IT WAS NOTED THE PATIENT ¿DIDN¿T WANT¿ TO CAUSE A FUSS BUT ¿HER PUMP SIMPLY STOPPED¿. THE DEVICE SYSTEM WAS USED TO DELIVER BACLOFEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301177 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00044 YR