BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE TRIPOLE 16 LEAD, 60 CM

    MDR report key: 2100676 · Received May 17, 2011

    Report

    Report Number
    1627487-2011-00680
    Event Type
    Injury
    Date Received
    May 17, 2011
    Date of Event
    April 18, 2011
    Report Date
    April 18, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS REVIEWED WERE FOUND TO MEET SPECIFICATIONS AND NO ANOMALIES WERE FOUND. THE LEADS WERE RETURNED INCOMPLETE. AS SUCH, NO FUNCTIONAL TESTING COULD BE PERFORMED. CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. SJM HAS LIMITED INFORMATION 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 WAS IMPLANTED WITH AN SCS SYSTEM ON (B)(6) 2010. IT WAS REPORTED THAT THE PT UNDERWENT A SURGICAL PROCEDURE TO MOVE HIS LEAD TO A DIFFERENT VERTEBRAE LEVEL. DESPITE THE SURGICAL INTERVENTION ADN SEVERAL SUBSEQUENT REPROGRAMMING SESSIONS, THE PT HAS BEEN UNABLE TO ACHIEVE EFFECTIVE STIMULATION RELIEF. THE PT'S SCS SYSTEM WAS EXPLANTED AT HIS REQUEST.

    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 3219 2884506

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention SCS IPG: MODEL: 3788| IMPLANT: