BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 1150248 · Received September 3, 2008

    Report

    Report Number
    3004209178-2008-05406
    Event Type
    Injury
    Date Received
    September 3, 2008
    Date of Event
    July 11, 2008
    Report Date
    August 5, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED TO THE MFR FOR ANALYSIS WHICH IS NOT COMPLETE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    THE PT'S SYSTEM WAS EXPLANTED DUE TO AN INFECTION. NO SYMPTOMS OR OUTCOME WERE REPORTED. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFO BECOMES AVAILABLE.

    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 59 YR Required Intervention IMPLANTED| LEAD MODEL 3888 LOT# J0406150V| EXPLANTED| EXPLANTED| EXPLANTED:| PROGRAMMER MODEL 7435 LOT# NFT038699P| IMPLANTED| LEAD MODEL 3888 LOT# J0406443V| EXPLANTED| IMPLANTED:| EXTENSION MODEL 7489 LOT# NHU041219V| IMPLANTED| EXTENSION MODEL 7489 LOT# NHU041218V