BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE PRIME ADVANCED

    MDR report key: 1040054 · Received May 7, 2008

    Report

    Report Number
    3004209178-2008-02451
    Event Type
    Injury
    Date Received
    May 7, 2008
    Date of Event
    January 1, 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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD AN INFECTION AND SHOCKING IN THE DEVICE POCKET. THE DEVICE HAS BEEN EXPLANTED. 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 RESTORE PRIME ADVANCED LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 37702 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXPLANTED:| EXTENSION MODEL 37082| EXPLANTED:| LEAD MODEL 3998| EXPLANTED:| LEAD MODEL 3778| PROGRAMMER MODEL 37742