BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 2182203 · Received July 7, 2011

    Report

    Report Number
    3007566237-2011-05201
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    May 25, 2011
    Report Date
    June 14, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT HEATING REMAINED AFTER RECHARGING OF DEVICE. PT'S POCKET HAD BEEN SORE AND POSSIBLE LOCATION ISSUE (GETS CAUGHT ON CHAIRS). SYMPTOMS WERE STATED BY PHYSICIAN TO BE RELATED TO DEVICE MOVING TOO SHALLOW TO SKIN SURFACE CAUSING IRRITATION AND INFLAMMATION. PT WAS SCHEDULED FOR A POCKET REVISION TO PLACE DEVICE DEEPER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE SENSOR LGW MEDTRONIC NEUROMODULATION 37714 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention