BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1222430 · Received November 5, 2008

    Report

    Report Number
    2182207-2008-07225
    Event Type
    Injury
    Date Received
    November 5, 2008
    Date of Event
    September 1, 2008
    Report Date
    October 8, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PUMP DOSE WAS INCREASED AT THE APRIL AND JUNE PUMP REFILLS. AT THE AUGUST REFILL, THE PUMP WAS REFILLED, BUT NOT INCREASED. THERE HAD BEEN NO PROBLEMS DURING THAT TIME. IN 2008, THE PATIENT WAS HOSPITALIZED WITH CARDIAC PROBLEMS. DURING THE TIME SHE WAS IN THE HOSPITAL, "CATHETERISM" WAS DONE. AT ABOUT 5 DAYS LATER, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. SHE BEGAN TO "FEEL BAD", WAS ANXIOUS , AND HAD PAIN. AT ABOUT SIX DAYS LATER, THE PUMP ALARM WAS SOUNDING. THE NEXT DAY, THE PATIENT CAME TO THE CLINIC, BECAUSE SHE WASN'T FEELING WELL. THE PUMP WAS INTERROGATED; A PUMP MOTOR STALL WAS FOUND FROM ABOUT THREE WEEKS PRIOR, WITH A "STOPPED PUMP PERIOD MAY EXCEED TUBE SET" MESSAGE 24 HOURS LATER. THE PUMP WAS INTERROGATED AGAIN BEFORE THE PATIENT LEFT, AND WAS STILL STALLED. THE PATIENT WAS SCHEDULED TO COME BACK TO THE CLINIC IN A COUPLE OF DAYS. NO DEVICE TROUBLESHOOTING WAS PLANNED; THE HEALTHCARE PROFESSIONAL PLANNED TO EXPLANT THE PUMP. THERE WAS NO PATIENT INJURY. THE PUMP WAS USED TO DELIVER MORPHINE AND BUPIVACAINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 8637-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization