BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE TRIPOLE 16 LEAD, 60 CM

    MDR report key: 1970281 · Received January 14, 2011

    Report

    Report Number
    1627487-2011-00091
    Event Type
    Injury
    Date Received
    January 14, 2011
    Date of Event
    September 17, 2010
    Report Date
    September 17, 2010
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    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

    THE PT RECEIVED HER SCS SYSTEM ON (B)(6) 2009 CONSISTING OF AN IPG AND SURGICAL LEAD. IT WAS REPORTED THAT SINCE IMPLANT, THE PT'S THERAPY COVERAGE HAS BECOME INEFFECTIVE. THE PHYSICIAN SUSPECTED THAT THE ALLEGED ISSUE STEMMED FROM LEAD PLACEMENT. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2010 TO RESOLVE THIS ISSUE. AT THAT TIME, THE PHYSICIAN ELECTED TO REPLACE THE PT'S SCS SYSTEM. THE EXPLANTED LEAD WAS DISCARDED AND WILL NOT BE RETURNED TO THE MFR. F/U ON THE PT FOUND NO FURTHER ISSUES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE TRIPOLE 16 LEAD, 60 CM SPINAL CORD STIMULATION LEAD LGW ST JUDE MEDICAL - NEUROMODULATION DIVISION 3219 175788

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention