BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 2940659 · Received January 29, 2013

    Report

    Report Number
    1627487-2013-10030
    Event Type
    Injury
    Date Received
    January 29, 2013
    Date of Event
    January 11, 2013
    Report Date
    January 11, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DEVICE 1 OF 2. REFERENCE MFR REPORT: 1627487-2013-10031. IT WAS REPORTED, THE PT ((B)(6)) PULLED HIS BACK AND SUDDENLY STOPPED FEELING STIMULATION. DIAGNOSTIC TESTING IDENTIFIED HIGH AND INVALID IMPEDANCES. IT IS SUSPECTED THAT THE SCS LEAD HAS COME OUT OF THE IPG. THE PT WAS SENT FOR AN X-RAY (RESULTS PENDING) AND WILL F/U WITH HIS PHYSICIAN AT A LATER DATE TO DETERMINE THE NEXT COURSE OF ACTION. DEVICE INFO FOR THE IPG (DEVICE 2) HAS BEEN REQUESTED; HOWEVER, NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38956 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3689109

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention