BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE 4

    MDR report key: 2875148 · Received December 12, 2012

    Report

    Report Number
    1627487-2012-06915
    Event Type
    Injury
    Date Received
    December 12, 2012
    Date of Event
    November 16, 2012
    Report Date
    November 16, 2012
    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

    DEVICE 1 OF 3. REFERENCE MFR. REPORT# 1627487-2012-06916. REFERENCE MFR. REPORT# 1627487-2012-06917. THE PATIENT HAS THREE LEADS (FOR OFF-LABEL USE). IT WAS REPORTED THE PATIENT IS EXPERIENCING INADEQUATE AND UNCOMFORTABLE STIMULATION. REPROGRAMMING WAS UNSUCCESSFUL. THE PATIENT UNDERWENT A FLUOROSCOPY AND NO ANOMALIES WERE FOUND. THE PATIENT WILL UNDERGO SURGICAL INTERVENTION TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE 4 SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3254 172369

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention IMPLANT:| IMPLANT:| SCS IPG: MODEL 3716| SCS IPG: MODEL 3788| IMPLANT:| SCS ANCHOR: MODEL 1192