BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE S8

    MDR report key: 2854178 · Received November 28, 2012

    Report

    Report Number
    1627487-2012-06827
    Event Type
    Injury
    Date Received
    November 28, 2012
    Date of Event
    October 31, 2012
    Report Date
    October 31, 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 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

    DEVICE 3 OF 3. REFERENCE MFR. REPORT#: 1627487-2012-06825, REFERENCE MFR. REPORT#: 1627487-2012-06826. IT WAS REPORTED, THE PT WAS NOT RECEIVING ADEQUATE COVERAGE. AS A RESULT, THE PT'S SCS SYSTEM WAS EXPLANTED. THE EXPLANTED PRODUCT WILL NOT BE RETURNED TO SJM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE S8 SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3286 3263526

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention SCS ANCHORS: MODEL 1192(2)| EXPLANT:| EXPLANT:| SCS IPG: MODEL 3788| EXPLANT:| IMPLANT:| IMPLANT:| IMPLANT:| SCS EXTENSION: MODEL 3341