BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE 44 LEAD KIT, 60CM LENGTH

    MDR report key: 2033501 · Received March 24, 2011

    Report

    Report Number
    1627487-2011-00391
    Event Type
    Injury
    Date Received
    March 24, 2011
    Date of Event
    February 24, 2011
    Report Date
    February 24, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIV.
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 ((B)(6)) WAS IMPLANTED WITH A SURGICAL LEAD ON (B)(6) 2011. IT WAS REPORTED THAT THE PT LOST STIMULATION. THE PHYSICIAN EXPLANTED AND REPLACED THE LEAD DUE TO A BROKEN ELECTRODE. THE PT'S IPG REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE 44 LEAD KIT, 60CM LENGTH SPINAL CORD STIMULATION LEAD LGW ST JUDE MEDICAL - NEUROMODULATION DIV. 3244 2838236

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SCS IPG: MODEL: UNK