BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE PRIME ADVANCED

    MDR report key: 1192064 · Received October 7, 2008

    Report

    Report Number
    3004209178-2008-06377
    Event Type
    Injury
    Date Received
    October 7, 2008
    Date of Event
    August 1, 2008
    Report Date
    September 11, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PATIENT'S SYSTEM WAS REMOVED DUE TO DISCOMFORT (DEVICE LOCATION/POSITON) AND INFECTION. NO ADDITIONAL DETAILS WERE PROVIDED. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT 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| LEAD MODEL 3778| EXPLANTED| LEAD MODEL 3778| PROGRAMMER MODEL 37743