BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAMITRODE 44C

    MDR report key: 2915343 · Received December 28, 2012

    Report

    Report Number
    1627487-2012-11927
    Event Type
    Malfunction
    Date Received
    December 28, 2012
    Date of Event
    December 7, 2012
    Report Date
    December 7, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 3 OF 4. REFERENCE MFR REPORT: 1627487-2012-11925, 11926, 11928. IT WAS REPORTED BY THE PT HE HAD NEVER RECEIVED RELIEF FROM THE STIMULATION. THE PT REPORTED HE HAD STOPPED CHARGING THE IPG ABOUT 3 TO 4 YEARS AGO. IT WAS ALSO REPORTED THE PT HAD PARTICIPATED IN A SLEEP STUDY RECENTLY AND HAD FELT TINGLING IN HIS FOOT. ATTEMPTS TO COMMUNICATE WITH THE IPG USING EXTERNAL DEVICES WERE UNSUCCESSFUL. THE PT WAS ADVISED TO DISCUSS THE TINGLING WITH THE PHYSICIAN. IT WAS UNDETERMINED WHICH LEADS WERE IMPLANTED, SO ALL POSSIBLE LEADS ARE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE 44C SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3245 57487

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention SCS EXTENSION: MODEL 3383| IMPLANT DATE: