BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED RECHARGEABLE

    MDR report key: 1133123 · Received August 22, 2008

    Report

    Report Number
    3004209178-2008-05185
    Event Type
    Malfunction
    Date Received
    August 22, 2008
    Date of Event
    July 1, 2008
    Report Date
    July 29, 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
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE PATIENT EXPERIENCED NO STIMULATION SENSATION IN HER AREA OF PARESTHESIA AFTER AIRPORT SECURITY USED THE SECURITY WAND ON HER NUMEROUS TIMES. THE PATIENT WAS AT HOME AT THE TIME OF THE COMPLAINT AND REDIRECTED TO HER HCP. 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 ADVANCED RECHARGEABLE LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 37713 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 37083| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3587A| PROGRAMMER: MODEL 37742| RECHARGER: MODEL 37752