BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED RECHARGEABLE

    MDR report key: 1213299 · Received October 27, 2008

    Report

    Report Number
    3004209178-2008-06904
    Event Type
    Injury
    Date Received
    October 27, 2008
    Date of Event
    August 1, 2008
    Report Date
    September 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
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PATIENT FELT STIMULATION IN THE WRONG AREA. A SPINAL X-RAY TAKEN IN 2008 REVEALED THAT THE EPIDURAL LEAD TIPS HAD MOVED UP TO THE T9 LEVEL. THERE WAS NO KNOWN INCIDENT OR ACCIDENT RELATED TO THE COMPLAINT. THE LEADS WERE REVISED. THE HCP REPORTED THE PATIENT OUTCOME AS 'NO INJURY'.

    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 3777| IMPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3777