BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1040540 · Received May 9, 2008

    Report

    Report Number
    3004209178-2008-02528
    Event Type
    Injury
    Date Received
    May 9, 2008
    Date of Event
    April 1, 2008
    Report Date
    April 11, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT DEVELOPED AN INFECTION 2 WEEKS AFTER PUMP IMPLANT. PERIOPERATIVE ANTIBIOTICS HAD BEEN ADMINISTERED. SUPERFICIAL WOUNDS BY THE DEVICE POCKET WERE THE PRIMARY SOURCE OF INFECTION. CULTURES OF DEVICE POCKET REVEALED STAPHYLOCOCCUS AUREUS. INFECTION SYMPTOMS INCLUDED REDNESS, SWELLING, AND DRAINAGE. THE PT WAS TREATED WITH BOTH INTRAVENOUS AND ORAL ANTIBIOTICS AND THE INFECTION RESOLVED. THE PT DID NOT DEVELOP MENINGITIS. THE PT WAS AT HOME. THE TYPE OF MEDICATION, CONCENTRATION, AND DAILY DOSE BEING ADMINISTERED VIA THE PUMP WERE NOT REPORTED; DEVICE REGISTRATION SYSTEM INDICATES LIORESAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXPLANTED| IMPLANTED| EXPLANTED| IMPLANTED| CATHETER MODEL 8703W| PROGRAMMER MODEL 8840| CATHETER MODEL 8596SC