BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3021336 · Received March 26, 2013

    Report

    Report Number
    3004209178-2013-04234
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Report Date
    February 26, 2013
    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

    PHYSICIAN PROGRAMMER MODEL: 8840, LOT # UNKNOWN, CATHETER MODEL: 8709SC, LOT # N181455009, IMPLANTED: (B)(6) 2009, EXPLANTED: UNKNOWN. PHYSICIAN PROGRAMMER MODEL: 8840, SERIAL # UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUMP WAS ALARMING DUE TO A ZERO RESERVOIR VOLUME REACHED. IT WAS REPORTED THE PUMP WAS REFILLED IN (B)(6) 2012 AND WOULD NOT NEED TO BE REVILED UNTIL (B)(6) 2013. IT WAS INDICATED THAT THE PUMP WAS REFILLED AND PROGRAMMED BUT NOT UPDATED. THE THERAPY THAT THE PATIENT WAS RECEIVING WAS "GOING FINE." THE PUMP WAS INFUSING LIORESAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123274 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1