BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2450128 · Received February 14, 2012

    Report

    Report Number
    3004209178-2012-00962
    Event Type
    Malfunction
    Date Received
    February 14, 2012
    Report Date
    January 27, 2012
    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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CATHETER MODEL: 8709SC, SERIAL #: (B)(4), IMPLANTED: (B)(6) 2010, EXPLANTED: UNK; CATHETER POUCH MODEL: 8590-1, LOT #: N230604, IMPLANTED: (B)(6) 2010, EXPLANTED: UNK; PHYSICIAN PROGRAMMER MODEL: 8840, SERIAL #: UNK; PROGRAMMER PTM MODEL: 8835, SERIAL #: (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: REGARDING THE PUMP MEMORY ERROR, THERE WAS NO EMI (ELECTROMAGNETIC INTERFERENCE) INVOLVED IN THE EVENT. THERE WAS NO FURTHER TROUBLESHOOTING OR ACTIONS PERFORMED. REGARDING THE PATIENT'S OUTCOME, THE PATIENT WAS RECEIVING EFFECTIVE THERAPY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP TELEMETRY CONFIRMED A PUMP MEMORY ALARM WAS OCCURRING. PUMP WAS OBSERVED TO BE IN A "STOPPED PUMP MODE" UPON RE-INTERROGATION. IT WAS STATED THAT THE MEMORY ERROR OCCURRED DURING THE PUMP UPDATE. THE PUMP WAS RE-PROGRAMMED TO COME OUT OF THE STOP MODE. DRUGS DELIVERED VIA THE DEVICE WERE MORPHINE AND BUPIVACAINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED; A FOLLOW-UP REPORT WILL BE SENT WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1