BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAMITRODE TRIPOLE 16

    MDR report key: 2911492 · Received November 28, 2012

    Report

    Report Number
    1627487-2012-14118
    Event Type
    Malfunction
    Date Received
    November 28, 2012
    Date of Event
    October 29, 2012
    Report Date
    October 29, 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 IS NO LONGER RECEIVING EFFECTIVE STIMULATION AND HIS STIMULATION WAS AUTO-REDUCING. AN SJM REP MET WITH THE PT AND LEAD DIAGNOSTICS SHOWED MULTIPLE INVALID IMPEDANCES. REPROGRAMMING WAS UNABLE TO RESOLVE THE ISSUE. THE PT HAS SUFFERED SEVERAL FALLS AND HAS NOT USED HIS SCS SYSTEM SINCE AUG 2012. THE PT IS WORKING WITH HIS PHYSICIAN TO DETERMINE THE NEXT COURSE OF ACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE TRIPOLE 16 SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3219 2777757

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention IMPLANT:| SCS IPG: MODEL 3788