BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 1885273 · Received October 25, 2010

    Report

    Report Number
    3004209178-2010-08431
    Event Type
    Malfunction
    Date Received
    October 25, 2010
    Date of Event
    January 1, 2010
    Report Date
    September 28, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A PT HAD SEROUS FLUID COMING FROM THEIR DEVICE POCKET SITE. THE PT WAS NOTED TO HAVE BEEN GOING IN AND OUT OF CONSCIOUSNESS. THE PT WAS FEBRILE, AND HAD A HIGH WHITE BLOOD CELL COUNT. A REFILL WAS CONDUCTED ABOUT 3 WEEKS FROM (B)(6) 2010. A PAIN CONSULTANT WAS REFERRED. THE PHYSICIAN WAS RETRIEVING INFO IN REGARDS TO REMOVING THE PUMP. THE PT'S OUTCOME, IN ADDITION TO THE TYPE MEDICATION, CONCENTRATION, AND DAILY DOSE BEING ADMINISTERED VIA THE PUMP WERE NOT REPORTED. ADDITIONAL INFO IS BEING REQUESTED FROM THE HCP, AND WILL BE PROVIDED IN A FOLLOW-UP REPORT AS IT BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR EXPLANTED:| CATHETER: MODEL 8709SC, LOT# N261059009| IMPLANTED:| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 8835, LOT# NPG018795N