BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE

    MDR report key: 3052829 · Received April 2, 2013

    Report

    Report Number
    1627487-2013-06122
    Event Type
    Injury
    Date Received
    April 2, 2013
    Date of Event
    March 11, 2013
    Report Date
    March 11, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 1 OF 4. REF MFR REPORT #S: 1627487-2013-06123, 1627487-2013-06123, 1627487-2013-06125. THE PT IS IMPLANTED WITH TWO LEADS FOR SUPRA-ORBITAL COVERAGE AND TWO LEADS FOR TEMPORAL COVERAGE (OFF-LABEL USE), ALL FROM DIFFERENT LOTS. IT WAS REPORTED THE PT HAD HER SUPRA-ORBITAL AND TEMPORAL LEADS REPOSITIONED TO IMPROVE COVERAGE OF STIMULATION. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135455 QUATTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3149 3629520

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention SCS EXTENSION, MODEL 3386 (2)| SCS IPG, MODEL 3716| IMPLANT DATE:| IMPLANT DATE: