BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE PRIME ADVANCED

    MDR report key: 1213068 · Received October 23, 2008

    Report

    Report Number
    3004209178-2008-06833
    Event Type
    Malfunction
    Date Received
    October 23, 2008
    Date of Event
    September 1, 2008
    Report Date
    September 25, 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
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE PATIENT FELL OUT OF A CHAIR AND HAD PAIN AT HER IMPLANTABLE NEUROSTIMULATOR LOCATION SINCE THEN. THE PATIENT EXPERIENCED SHOCKING IN HER AREA OF PARESTHESIA IF THE STIMULATION SETTINGS WERE TOO HIGH. AN APPOINTMENT WITH THE HCP HAD BEEN MADE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION 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 74 YR LEAD: MODEL 3777| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3777| IMPLANTED:| EXPLANTED: