BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE TRIPOLE 16 SURGICAL LEAD

    MDR report key: 2103716 · Received May 24, 2011

    Report

    Report Number
    1627487-2011-01547
    Event Type
    Injury
    Date Received
    May 24, 2011
    Date of Event
    February 9, 2011
    Report Date
    February 9, 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

    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 RECEIVED HER SCS SYSTEM, INCLUDING A SURGICAL LEAD, ON (B)(6) 2010. IT WAS REPORTED THAT THE PT COMPLAINED OF INEFFECTIVE STIMULATION. THE PHYSICIAN DECIDED TO EXPLANT THE LEAD ON (B)(6) 2011 AND RETRIAL THE PT AT A LATER DATE. THE EXPLANTED LEAD WAS DISCARDED BY THE FACILITY; THEREFORE, IT WILL NOT BE RETURNED TO THE MFR FOR EVALUATION. NO FURTHER PT COMPLICATIONS WERE REPORTED.

    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 3057064

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention SCS IPG: MODEL 3716| IMPLANTED: