BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3061097 · Received April 16, 2013

    Report

    Report Number
    3007566237-2013-01297
    Event Type
    Injury
    Date Received
    April 16, 2013
    Report Date
    March 18, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    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 NEU_UNKNOWN_CATH, SERIAL # UNKNOWN, PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP WAS PUT IN PUMP STOP MODE. THE PATIENT WAS INPATIENT "FOR REHAB" AND WAS HAVING "A PROBLEM WITH ASTHMA." THE PATIENT "PROGRESSIVELY GOT WORSE" AND WAS PUT IN INTENSIVE CARE UNIT WITH A FEVER OF 107 AND WAS "KIND OF COMATOSE." IT WAS UNKNOWN IF THE EVENT WAS DEVICE RELATED. THE HEALTHCARE PROVIDER WAS CONCERNED THAT IT "MIGHT" HAVE BEEN MENINGITIS. IT WAS STATED THAT THE NEUROLOGIST DID NOT WANT THE DEVICE SET TO MINIMUM RATE BUT "COMPLETELY OFF." THE DEVICE SYSTEM WAS USED TO INFUSE MORPHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163349 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R