BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE RECHARGEABLE NEUROSTIMULATOR

    MDR report key: 1192069 · Received October 7, 2008

    Report

    Report Number
    3004209178-2008-06393
    Event Type
    Injury
    Date Received
    October 7, 2008
    Date of Event
    September 1, 2008
    Report Date
    September 9, 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
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT EXPERIENCED BURNING SENSATIONS WITH POSITON CHANGES OVER THE PAST 3-4 MONTHS. THE BURNING SENSATION "GOES AWAY" WHEN THE DEVICE IS OFF. THE HCP MAY REVISE DUE TO A POSSIBLE FLUID SHORT IF THE PT'S SYMPTOMS WORSEN. NO FURTHER OUTCOME WAS REPORTED. 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 RECHARGEABLE NEUROSTIMULATOR LGW MEDTRONIC PUERTO RICO OPERATIONS CO 37711 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXPLANTED| LEAD MODEL 3777| LEAD MODEL 3777| EXPLANTED