BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE PRIME ADVANCED

    MDR report key: 1053619 · Received May 23, 2008

    Report

    Report Number
    3004209178-2008-02777
    Event Type
    Injury
    Date Received
    May 23, 2008
    Date of Event
    April 1, 2008
    Report Date
    April 23, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT NOTED AN EOS MESSAGE. THE HCP REPORTED THE BATTERY WAS DEPLETED DUE TO HIGH SETTINGS. THE PT ALSO EXPERIENCED INFECTION SYMPTOMS OF PAIN, REDNESS, AND DRAINAGE AT THE PUNCTURE AND IPG SITES. THE WOUNDS WERE CULTURED AND MRSA WAS ISOLATED. THE DEVICE WAS EXPLANTED WITH PLANS TO REIMPLANT IN THE FUTURE AFTER THE INFECTION HAD RESOLVED. THE PT WAS TREATED WITH IV AND ORAL ANTIBIOTICS. THE PT RECOVERED WITHOUT SEQUELA.

    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 IMPLANTED:| EXPLANTED:| IMPLANTED:| LEAD MODEL 3778 LOT# V011708| EXPLANTED:| IMPLANTED:| LEAD MODEL 3778 LOT# 071786013| PROGRAMMER MODEL 37742 LOT# NJD065340N| EXPLANTED: