BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 1252011 · Received December 4, 2008

    Report

    Report Number
    3004209178-2008-08005
    Event Type
    Injury
    Date Received
    December 4, 2008
    Date of Event
    October 1, 2008
    Report Date
    November 7, 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
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT'S "IMPLANT WAS CHECKED" AND THE PT WAS SCHEDULED FOR SURGERY "TO REPLACE THE PERCUTANEOUS LEADS WITH PADDLE LEADS AND REVISE THE POCKET." NO FURTHER DETAILS WERE PROVIDED ON PT SYMPTOMS OR DEVICE FAILURES. ADD'L INFO HAS BEEN REQUESTED.

    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 51 YR Required Intervention UNK CONVERSION TYPE: MODEL 3550-09| EXPLANTED| EXPLANTED| LEAD: MODEL 3887| PROGRAMMER: MODEL 7435 LOT# NFT008894P| EXTENSION: MODEL 7495-51| IMPLANTED| EXPLANTED| LOT# N0038324