BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE S8

    MDR report key: 2940630 · Received January 30, 2013

    Report

    Report Number
    1627487-2013-01114
    Event Type
    Injury
    Date Received
    January 30, 2013
    Date of Event
    January 4, 2013
    Report Date
    January 10, 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

    THE PT HAS TWO LEADS IMPLANTED WITH THE SAME LOT NUMBER. IT WAS REPORTED THE PT IS EXPERIENCING UNINTENDED STIMULATION IN HIS ABDOMEN. A SJM REPRESENTATIVE MET WITH THE PT AND REPROGRAMMING WAS UNABLE TO CAPTURE COVERAGE IN THE PT'S PAIN AREAS. THE PT IS PENDING FOLLOW UP FOR REPROGRAMMING AGAIN IN THREE WEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41582 LAMITRODE S8 SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3286 3767559

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention IMPLANT DATE:| SCS ANCHOR: MODEL 1192 (2)| IMPLANT DATE:| SCS IPG: MODEL 3788