BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAMITRODE TRIPOLE 16 SURGICAL LEAD

    MDR report key: 2080257 · Received April 7, 2011

    Report

    Report Number
    1627487-2011-02412
    Event Type
    Malfunction
    Date Received
    April 7, 2011
    Date of Event
    March 9, 2011
    Report Date
    March 9, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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 RECEIVED HIS SCS SYSTEM, INCLUDING A SURGICAL LEAD, ON (B)(6) 2010. IT WAS REPORTED THE PATIENT CANNOT INCREASE IS STIMULATION AMPLITUDE. DIAGNOSTIC TESTING OF THE LEAD FOUND ALL CONTACTS WERE INVALID. AN X-RAY WAS TAKEN, HOWEVER, AS A RESULT OF THE QUALITY OF THE X-RAY, THE PHYSICIAN WAS UNABLE TO CONFIRM ANY VISUAL ANOMALIES IN THE SYSTEM. THE PATIENT IS CONTINUING TO WORK CLOSELY WITH HIS PHYSICIAN TO DETERMINE THE NEXT COURSE OF ACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE TRIPOLE 16 SURGICAL LEAD SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3219 2891020

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention