BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1040273 · Received May 8, 2008

    Report

    Report Number
    2182207-2008-02488
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    June 1, 2005
    Report Date
    April 9, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PUMP WAS REMOVED DUE TO INFECTION AND REPLACED SEVERAL MONTHS LATER. NO SYMPTOMS OR OUTCOME WERE REPORTED. ADD'L INFO HAS BEEN REQUESTED FROM HCP, BUT WAS NOT AVAILABLE ON THE DATE OF THE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXPLANTED| CATHETER MODEL 8709 LOT# J12256R01| IMPLANTED| PROGRAMMER MODEL 8840 LOT#UNK