BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1082599 · Received July 25, 2008

    Report

    Report Number
    3004209178-2008-04402
    Event Type
    Injury
    Date Received
    July 25, 2008
    Date of Event
    May 1, 2008
    Report Date
    July 3, 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
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED, VIA A SURVEY RESPONSE THAT THE PT'S PUMP HAD FAILED. AN INFECTION WAS ALSO REPORTED. THE PUMP WAS REMOVED. SPECIFIC SYMPTOMS WERE NOT REPORTED. THE REPORT ALSO INDICATED THAT THE PT'S ABILITY TO PERFORM DAILY ACTIVITIES HAD SOMEWHAT IMPROVED WITH THE USE OF THE DEVICE. THE TYPE OF MEDICATION, CONCENTRATION, AND DAILY DOSE BEING ADMINISTERED VIA THE PUMP WERE NOT REPORTED. ADD'L INFO HAS BEEN REQUESTED FROM THE HCP, A FOLLOW-UP REPORT WILL BE SENT IF ADD'L INFO BECOMES AVAILABLE.

    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 CATHETER MODEL 8578 LOT# N137748| IMPLANTED:| PROGRAMMER MODEL 8840 LOT# UNK| IMPLANTED:| EXPLANTED:| CATHETER MODEL 8709 LOT# L57095| EXPLANTED: