BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE 88

    MDR report key: 3001509 · Received March 5, 2013

    Report

    Report Number
    1627487-2013-10076
    Event Type
    Injury
    Date Received
    March 5, 2013
    Date of Event
    October 1, 2012
    Report Date
    February 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 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

    IT WAS REPORTED, THE PT ((B)(6)) WAS NO LONGER FEELING STIMULATION. IT WAS ORIGINALLY THOUGHT THE IPG WAS DEPLETED; HOWEVER, UPON FURTHER INVESTIGATION, IT WAS IDENTIFIED THE IPG WAS FUNCTIONING PROPERLY, BUT THERE WERE IMPEDANCE ISSUES WITH THE LEAD. REPROGRAMMING DID NOT RESOLVE THE ISSUE. F/U INFO REVEALED THE FACILITY WILL SEE THE PT AGAIN IN APPROX 3 MONTHS. THE NEXT COURSE OF ACTION HAS NOT BEEN DETERMINED. NOTE: THE PT'S SYSTEM IS USED FOR OCCIPITAL NERVE STIMULATION (OFF-LABEL).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93057 LAMITRODE 88 SCS LEAD LGW ST JUDE MEDICAL - NEUROMODULATION 3288 3093165

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention