BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2950394 · Received February 8, 2013

    Report

    Report Number
    3007566237-2013-00425
    Event Type
    Injury
    Date Received
    February 8, 2013
    Report Date
    January 22, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8703W, LOT# L35606, IMPLANTED: (B)(6) 1995. PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT'S PHYSICIANS WERE CONSIDERING REPLACING THE PATIENT'S PUMP DUE TO THE BATTERY NEARING THE END OF ITS LIFE. THE PATIENT WAS IN THE HOSPITAL, AND THE PHYSICIAN DID NOT WANT TO REPLACE THE PUMP AT THIS TIME DUE TO AN INFECTION THAT COULD POTENTIALLY SPREAD AND "DO SOME DAMAGE." THE PATIENT HAD A TRACHEAL TUBE AND HAD LUNG PROBLEMS. LEAVING THE PUMP INSIDE THE PATIENT'S BODY, REPLACING THE DRUG WITH SALINE UNTIL THE PATIENT WAS HEALTHIER AND COULD HAVE THE SURGERY WAS DISCUSSED. THE PUMP WAS DELIVERING LIORESAL. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT IT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54326 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O