BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1980327 · Received February 3, 2011

    Report

    Report Number
    3004209178-2011-00872
    Event Type
    Injury
    Date Received
    February 3, 2011
    Date of Event
    January 28, 2011
    Report Date
    January 28, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT A PUMP REFILL SESSION ON (B)(6) 2010, 1ML WAS PULLED FROM THE PUMP AND 6.2ML WERE EXPECTED. THE PATIENT'S MEDICATION WAS CHANGED FROM BACLOFEN 500 TO 2000, BUT THE AMOUNT THAT THE PATIENT WAS TO RECEIVE WAS UNCHANGED. THE NEXT DAY THE PATIENT HAD TO BE WOKEN UP AS SHE DID NOT HEAR HER ALARM. SHE HAD DIFFICULTY AMBULATING DUE TO LOW TONE IN HER LEGS. THE PATIENT WAS LETHARGIC, AND EXPERIENCED NAUSEA AND VOMITING AND WAS ADMITTED TO THE HOSPITAL. THE PHYSICIAN WAS CONCERNED WITH HER SOMNOLENCE AND THE RISK OF ASPIRATION, SO SHE WAS MONITORED IN THE HOSPITAL CLOSELY. THE PHYSICIAN WAS ALSO CONCERNED WITH HER MEDICAL CONDITION WHICH COULD DECLINE SINCE THEY WERE NOT 100% CERTAIN OF THE ISSUE WITH THE BACLOFEN. THE PUMP WAS INTERROGATED AND APPEARED TO BE WORKING FINE. THE PUMP WAS REPROGRAMMED TO 244MCG/ML OF BACLOFEN. THE HCP STATED THAT IT WAS POSSIBLE THAT SINCE SHE RECEIVED A BRIDGE DOSE OF THE BACLOFEN, SHE MAY HAVE RECEIVED FOUR TIMES THE ANTICIPATED DOSE FOR ABOUT 4 HOURS IF THERE WAS A MISCALCULATION OF THE CATHETER LENGTH. THEY PLANNED TO OBSERVE HER OVERNIGHT TO SEE HOW SHE WAS FUNCTIONING IN THE MORNING. THEY WOULD DETERMINE AT THAT TIME IF THERE WERE ADDITIONAL TREATMENTS NEEDED OR IF SHE WAS ABLE TO BE DISCHARGED HOME. 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 PUERTO RICO OPERATIONS CO., JUNCOS 8637-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Hospitalization| R IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8709SC, LOT# N209312014