BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 1151325 · Received September 4, 2008

    Report

    Report Number
    3004209178-2008-05457
    Event Type
    Injury
    Date Received
    September 4, 2008
    Date of Event
    July 24, 2008
    Report Date
    July 24, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD WAS RETURNED FOR ANALYSIS. PRELIMINARY DEVICE ANALYSIS WAS NOT AVAILABLE ON THE DATE OF THIS REPORT. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN DEVICE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT SURGICAL REPLACEMENT OF THE LEAD BECAUSE THE PATIENT WAS NO LONGER RECEIVING BENEFICIAL STIMULATION. THE PATIENT HAD UNDERGONE A RECENT REVISION (SEE MFR REPORT #3004209178-2008-05456). THE PATIENT RECOVERED WITHOUT SEQUELA.

    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 77 YR Required Intervention EXPLANTED| LEAD MODEL 3998 LOT# V003826| PROGRAMMER MODEL 7435 LOT# NFT054182P| EXTENSION MODEL 7489 LOT# NHU172385V| EXTENSION MODEL 7489 LOT# NHU172384V| EXPLANTED| EXPLANTED