BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAMITRODE 44C

    MDR report key: 2900786 · Received December 12, 2012

    Report

    Report Number
    1627487-2012-12772
    Event Type
    Malfunction
    Date Received
    December 12, 2012
    Date of Event
    November 20, 2012
    Report Date
    November 20, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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

    IT WAS REPORTED THE PT EXPERIENCED INTERMITTENT STIMULATION. THE SJM REP MET WITH THE PT WHO REPORTED THE INTERMITTENT STIMULATION IS RESOLVED. THE SJM REP PERFORMED DIAGNOSTIC TESTS ON THE SYS AND FOUND NO ANOMALIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE 44C SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3245 84235

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention IMPLANT:| SCS EXT: MODEL 3383| IMPLANT:| SCS IPG: MODEL 3716