BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED RECHARGEABLE

    MDR report key: 1213280 · Received October 27, 2008

    Report

    Report Number
    3004209178-2008-06909
    Event Type
    Injury
    Date Received
    October 27, 2008
    Report Date
    September 26, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT DEVELOPED A "BIG LUMP" OVER THE IMPLANT SITE. AN INFECTION DEVELOPED. THE DEVICE WAS REMOVED DUE TO THE INFECTION. NO PATIENT SYMPTOMS WERE REPORTED. THE PATIENT RETURNED HOME FOLLOWING EXPLANT OF THE DEVICE. AN EXTERNAL TENS UNIT WAS NOW BEING USED TO TREAT THE PATIENT'S PAIN FOR WHICH THE DEVICE HAD BEEN IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ADVANCED RECHARGEABLE LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 37713 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXPLANTED:| LEAD: MODEL 39565| EXPLANTED:| EXTENSION: MODEL 37081| EXPLANTED:| EXTENSION: MODEL 37081