BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE S4 SURGICAL LEAD

    MDR report key: 2051065 · Received April 5, 2011

    Report

    Report Number
    1627487-2011-02400
    Event Type
    Injury
    Date Received
    April 5, 2011
    Date of Event
    March 7, 2011
    Report Date
    March 7, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MFR'S EVAL: THE RETURNED PRODUCT WAS NOT ANALYZED AS THE COMPLAINT OF LEAD PRODUCT WAS NOT ANALYZED AS THE COMPLAINT OF LEAD MIGRATION COULD NOT BE CONFIRMED VIA LABORATORY TESTING. 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

    THE PT RECEIVED HIS SCS SYSTEM, INCLUDING A SURGICAL LEAD, ON (B)(6) 2010. IT WAS REPORTED THE LEAD WAS SCHEDULED TO BE SURGICALLY REPOSITIONED DUE TO MIGRATION. DURING THE REVISION, THE LEAD WAS DAMAGED. THE LEAD WAS EXPLANTED BUT, DUE TO THE PT'S ANATOMY, THE LEAD COULD NOT BE REPLACED. NO FURTHER PT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE S4 SURGICAL LEAD SPINAL CORD STIMULATION LEAD LGW ST JUDE MEDICAL - NEUROMODULATION 3246 3108759

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention SCS IPG, MODEL: 3788| IMPLANTED: