BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE 4

    MDR report key: 3010651 · Received March 14, 2013

    Report

    Report Number
    1627487-2013-02364
    Event Type
    Injury
    Date Received
    March 14, 2013
    Date of Event
    February 20, 2013
    Report Date
    February 20, 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
    TX, 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

    IT WAS REPORTED THE PATIENT NO LONGER FELT EFFECTIVE STIMULATION COVERAGE FOR HIS ELBOW PAIN. DIAGNOSTIC TESTING REVEALED INVALID IMPEDANCE READINGS ON TWO LEAD CONTACTS. NO ANOMALIES WERE NOTED ON AN X-RAY. IT WAS REPORTED THE PHYSICIAN IS TRYING TO DETERMINE THE NEXT COURSE OF ACTION AND IS CONSIDERING SURGICAL INTERVENTION TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108539 LAMITRODE 4 SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3240 57990

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention IMPLANT DATE:| SCS IPG: MODEL 3716| IMPLANT DATE:| SCS LEAD, MODEL 3280| IMPLANT DATE:| SCS EXTENSION: MODEL 3383