BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4101856 · Received September 19, 2014

    Report

    Report Number
    3004209178-2014-17367
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    August 26, 2014
    Report Date
    August 26, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8578, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STARTING APPROXIMATELY TWENTY MINUTES AFTER THE IMPLANT OF THIS DEVICE, THE PATIENT REPORTED A DECREASED RESPONSIVENESS. AT APPROXIMATELY 1.25 HOURS, THE PATIENT REPORTEDLY RESPONDED NORMALLY. THE PUMP WAS CHECKED FOR PROGRAMMING ERRORS AND NONE WERE FOUND. THE PUMP WAS RUNNING PRIMING BOLUS AND DUE TO THE PATIENT¿S SYMPTOMS THE PUMP WAS PLACED INTO STOPPED PUMP MODE BY THE PHYSICIAN. THE PATIENT WAS BEING OBSERVED IN THE HOSPITAL. IT WAS UNKNOWN IF ANY DIAGNOSTIC TESTING OR TROUBLESHOOTING WAS PERFORMED, IF THE ISSUE WAS RESOLVED OR THE CAUSE DETERMINED. THE PHYSICIAN WAS PROVIDED WITH A REFILL KIT AND A CATHETER ACCESS KIT IF THE NEED WAS FELT TO REMOVE THE DRUG FROM THE SYSTEM. AT THE TIME OF THE REPORT THE PATIENT'S STATUS WAS REPORTED AS ALIVE-NO INJURY. IT WAS LATER PROVIDED THAT THE PATIENT¿S PUMP WAS RE-STARTED AND THE PATIENT WAS DOING WELL AND RECEIVING EFFECTIVE THERAPY. THIS DEVICE SYSTEM DELIVERED CLONIDINE, HYDROMORPHONE, AND BUPIVACAINE. SHOULD ADDITIONAL INFORMATION BE RECEIVED A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582183 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR Hospitalization| R