BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE S8

    MDR report key: 2921629 · Received January 10, 2013

    Report

    Report Number
    1627487-2013-13048
    Event Type
    Injury
    Date Received
    January 10, 2013
    Date of Event
    December 19, 2012
    Report Date
    December 19, 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 2. REF MFR. REPORT: 1627487-2013-13049. IT WAS REPORTED THE PT WAS NOT RECEIVING STIMULATION COVERAGE ON HER RIGHT SIDE. REPROGRAMMING CONFIRMED THE ISSUE. THE PT ALSO STATED SHE WAS EXPERIENCING AS SHE DESCRIBED "IMMENSE PAIN" ON HER RIGHT SIDE. X-RAYS IDENTIFIED THE PT'S LEADS HAD MIGRATED TO THE LEFT SIDE. SURGICAL INTERVENTION MAY BE TAKEN AT A LATER DATE TO REPOSITION THE LEADS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14904 LAMITRODE S8 SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3286 3761856

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention IMPLANT DATE:| SCS ANCHOR, MODEL 1192 (2)