BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE

    MDR report key: 2980012 · Received February 22, 2013

    Report

    Report Number
    1627487-2013-03260
    Event Type
    Injury
    Date Received
    February 22, 2013
    Date of Event
    January 28, 2013
    Report Date
    January 28, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    K072462
    Adverse Event
    Yes
    Product Problem
    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 4 OF 4. REFERENCE MFR. REPORTS: 1627487-2013-03257 1627487-2013-03258 AND 1627487-2013-03259 THE PATIENT RECEIVED 4 SCS LEADS, 2 HAVE DIFFERENT LOT NUMBERS AND 2 HAVE THE SAME LOT NUMBER. IT WAS REPORTED THE PATIENT IS EXPERIENCING HEATING AT HIS SCS IPG POCKET SITE WHILE USING SYSTEM STIMULATION AND LAYING FLAT ON HIS BACK. IT WAS ALSO REPORTED THE PATIENT IS NO LONGER RECEIVING EFFECTIVE STIMULATION. THE PATIENT'S PERIPHERAL (OFF-LABEL) SCS LEAD STIMULATION HAS MOVED. ADDITIONALLY, THE PATIENT HAS LOST WEIGHT SINCE IMPLANT AND THE SCS EXTENSIONS CAN BE FELT THROUGH THE PATIENT'S SKIN. MOREOVER, THE PATIENT'S EPIDURAL SCS LEADS ARE PROVIDING STIMULATION ON THE PATIENT'S RIGHT SIDE BUT NOT LEFT. THE PATIENT IS TO CONSULT WITH A PHYSICIAN TO ADDRESS THE ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77698 QUATTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3166 2890980

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention SCS EXTENSION: MODEL 3341 (2)| IMPLANT DATE: