BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE TRIPOLE 16 SURGICAL LEAD

    MDR report key: 2103662 · Received May 20, 2011

    Report

    Report Number
    1627487-2011-02631
    Event Type
    Injury
    Date Received
    May 20, 2011
    Date of Event
    April 21, 2011
    Report Date
    April 21, 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 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

    DEVICE 2 OF 2. REFERENCE MANUFACTURER REPORT: 1627487-2011-02630. THE PATIENT RECEIVED AN SCS SYSTEM, INCLUDING AN IPG AND A SURGICAL LEAD, ON (B)(6) 2010. IT WAS REPORTED THE IPG WAS EXPLANTED AND NOT REPLACED DUE TO INEFFECTIVE STIMULATION. THE LEADS WERE CAPPED AND LEFT IN THE PATIENT. THE IPG WAS RETAINED BY THE FACILITY. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    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 3108718

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention