BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAMITRODE 44 SURGICAL LEAD

    MDR report key: 2081893 · Received April 5, 2011

    Report

    Report Number
    1627487-2011-02399
    Event Type
    Malfunction
    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
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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

    THE PT REC'D AN SCS SYSTEM, INCLUDING A SURGICAL LEAD, ON (B)(6) 2010. IT WAS REPORTED THE PT WAS NO LONGER FEELING STIMULATION FROM THE SCS SYSTEM. DIAGNOSTIC TESTING OF THE LEAD FOUND UNACCEPTABLE IMPEDANCES ON ALL CONTACTS. THE PT WAS REFERRED FOR AN X-RAY OF THE SCS SYSTEM. SHE IS CONTINUING TO WORK CLOSELY WITH HER PHYSICIAN TO DETERMINE THE NEXT COURSE OF ACTION. NO PT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE 44 SURGICAL LEAD SPINAL CORD STIMULATION LEAD LGW ST JUDE MEDICAL - NEUROMODULATION 3244 2870863

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention IMPLANTED:| SCS IPG, MODEL: 3788