BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3093576 · Received May 6, 2013

    Report

    Report Number
    3007566237-2013-01536
    Event Type
    Injury
    Date Received
    May 6, 2013
    Report Date
    April 11, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8731, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS REPORTED THAT THE PATIENT STAYED IN THE HOSPITAL FOR 23 HOURS AND THEN WENT HOME. THE FOLLOWING FRIDAY, SHE WAS SEEN IN HER PHYSICIAN¿S OFFICE AND HER PUMP DOSE WAS INCREASED. THE PATIENT WAS DOING WELL.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PUMP WAS REPLACED BECAUSE IT WAS AT ITS END OF SERVICE (EOS). EOS OCCURRED (B)(6) 2013. THE PATIENT WAS TAKING ORAL MEDICATION UNTIL THE PUMP COULD BE REPLACED. THE PUMP HAD BEEN DELIVERING MORPHINE 60 MG/ML AT 8.5 MG/DAY. THE NEW PUMP WAS PRIMED AND CONNECTED TO THE EXISTING CATHETER. DURING THE REPLACEMENT, IT WAS NOTED THE CATHETER COULD NOT BE ASPIRATED. A PRIMING BOLUS WAS SET TO DELIVER 2.88 MG/DAY FOR THE FOLLOWING 98 HOURS. THE PHYSICIAN SAID "SHE'LL NEVER FEEL IT, SHE'S ON SO MUCH OF THE ORAL AND SHE'S STAYING OVERNIGHT". AFTER THE BOLUS, THE PUMP WAS SET TO DELIVER 0.75 MG/DAY TO "START THE PATIENT BACK UP AGAIN". FOUR DAYS LATER IT WAS LATER REPORTED THAT THE PATIENT WAS KEPT IN THE HOSPITAL OVERNIGHT FOR OBSERVATION AND WAS "DOING FINE". SHE HAD A FOLLOW-UP APPOINTMENT A WEEK AFTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197336 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR Hospitalization