BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 1230558 · Received November 13, 2008

    Report

    Report Number
    3004209178-2008-07450
    Event Type
    Injury
    Date Received
    November 13, 2008
    Date of Event
    January 1, 2008
    Report Date
    June 10, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED FOLLOWING AN INTERNAL AUDIT. THIS EVENT WAS ORIGINALLY REPORTED AS A FOLLOW UP REPORT FOR MFR REPORT # 3004209178200803846.

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PT DEVELOPED AN INFECTION. THE PT HAD POCKETS OF FLUID AND STITCH ABSCESSES. THE LEAD WAS EXPLANTED AND REPLACED. ADDITIONAL INFO HAS BEEN REQUESTED FROM THE HCP, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNERGY LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 7427 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXPLANTED:| LEAD: MODEL 3986A| EXTENSION: MODEL 7489| EXPLANTED: