BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3201684 · Received July 2, 2013

    Report

    Report Number
    3007566237-2013-00240
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    January 28, 2012
    Report Date
    January 31, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HEARD THEIR PUMP ALARMING. TELEMETRY WAS CONDUCTED, AND A MOTOR STALL WAS CONFIRMED. THE STOPPED PUMP DURATION WAS GREATER THAN 48 HOURS. THE PUMP DISPLAYED A WARNING THAT THE STOPPED PUMP DURATION MAY EXCEED TUBE-SET. THE MOTOR STALL RECOVERED. THIS EVENT WAS NOTICED TWICE IN THE EVENT LOGS. THE PATIENT EXPERIENCED WITHDRAWAL AND WAS TAKING ORAL MEDICATION TO MANAGE THEIR SYMPTOMS. THE PATIENT¿S SYMPTOMS INCLUDED NAUSEA, VOMITING, AND HEADACHES. THE PUMP HAD BEEN SCHEDULED TO BE REPLACED PRIOR TO THE PROBLEMS OCCURRING, BUT THE SURGERY WAS RESCHEDULED DUE TO A STORM. THE PUMP WAS REPLACED ON 2012-(B)(6), AND THE PATIENT WAS DOING ¿EXCELLENT.¿ THE DEVICE SYSTEM WAS BEING USED TO DELIVER DILAUDID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303249 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 00052 YR