BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3213984 · Received July 9, 2013

    Report

    Report Number
    3004209178-2013-11503
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    June 13, 2013
    Report Date
    June 13, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8780 LOT# SERIAL# (B)(4), IMPLANTED: 2013 (B)(6); PRODUCT TYPE CATHETER PRODUCT ID 8780 LOT# SERIAL# (B)(4), IMPLANTED: 2013 (B)(6); PRODUCT TYPE CATHETER PRODUCT ID NEU_UNKNOWN_PROG LOT# UNKNOWN; PRODUCT TYPE PROGRAMMER, PHYSICIAN. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8870; PRODUCT TYPE SOFTWARE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN WAS ATTEMPTING TO ACCESS THE PUMP FOR THE FIRST TIME SINCE IMPLANT AND A ¿PUMP MEMORY ERROR,¿ ¿PUMP AND CATHETER DATA IS INVALID¿ MESSAGE DISPLAYED. IT WAS CONFIRMED THAT THE SMII SOFTWARE VERSION WAS B.3. THE PHYSICIAN DECIDED TO WAIT TO PROGRAM THE INCREASE UNTIL HE TALKED WITH THE REP AND GOT AN UPDATED SOFTWARE CARD. THE DEVICE SYSTEM WAS USED TO DELIVER MORPHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312822 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR