BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3821568 · Received May 20, 2014

    Report

    Report Number
    3004209178-2014-09291
    Event Type
    Injury
    Date Received
    May 20, 2014
    Report Date
    April 26, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8835, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT PRODUCT ID: 8 596SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: CATHETER. PRODUCT ID: 8598A, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROVIDER. IT WAS REPORTED THAT THE SYMPTOMS THE PATIENT WAS EXPERIENCED WAS UNKNOWN. INFORMATION REPORTED FROM THE CONSUMER VIA THE HEALTHCARE PROVIDER INDICATED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL AND FOUND TO HAVE LIVER FAILURE. THE CAUSE OF THE EVENT WAS LIVER FAILURE AND WAS NOT PUMP RELATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS IN THE HOSPITAL TODAY AND WAS BEING TREATED FOR DELIRIUM. THE CAUSE OF THE DELIRIUM WAS NOT KNOWN AT THIS TIME, AND THE PUMP MAY BE ADJUSTED. THE PUMP WAS USED TO INFUSE FENTANYL AND BUPIVACAINE. IT WAS FURTHER REPORTED THE HCP (HEALTHCARE PROFESSIONAL) ONLY SAW THE PATIENT THE DAY THE PATIENT WAS IN THE HOSPITAL, AND THEY ONLY CHECKED THE PUMP. IT WAS FURTHER REPORTED NO TROUBLESHOOTING WAS PERFORMED AND THE PATIENTS STATUS WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299269 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR Other