BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE 8 LEAD, 60CM LENGTH

    MDR report key: 2130672 · Received June 14, 2011

    Report

    Report Number
    1627487-2011-00807
    Event Type
    Injury
    Date Received
    June 14, 2011
    Date of Event
    May 16, 2011
    Report Date
    May 16, 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
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION, RESULTS: THE LEAD WAS RETURNED INCOMPLETE. AS SUCH, NO FUNCTIONAL TESTING COULD BE PERFORMED. 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

    THE PATIENT'S IPG WAS REPLACED IPG ON (B)(6) 2011 (REFERENCE MFR. REPORT# 1627487-2011-02645). DURING INTRAOPERATIVE TESTING, IT WAS REPORTED THAT NO STIMULATION COULD BE FELT BY THE PATIENT FROM HIS SURGICAL LEAD. THE PHYSICIAN UTILIZED A DIFFERENT LEAD TO COMPLETE THE PROCEDURE AND EFFECTIVE THERAPY WAS CAPTURED AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE 8 LEAD, 60CM LENGTH SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3280 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention IMPLANTED:| SCS IPG: MODEL 3788