BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE S8 SURGICAL LEAD

    MDR report key: 2042072 · Received March 31, 2011

    Report

    Report Number
    1627487-2011-02395
    Event Type
    Injury
    Date Received
    March 31, 2011
    Date of Event
    March 3, 2011
    Report Date
    March 3, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    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

    DEVICE 1 OF 2. REFERENCE MANUFACTURER REPORT: 1627487-2011-02396. THE PT ((B)(6)) RECEIVED AN SCS SYSTEM, INCLUDING A SURGICAL LEAD AND AN EXTENSION, ON (B)(6) 2009. IT WAS REPORTED THE LEAD AND EXTENSION WERE EXPLANTED AND REPLACED DUE TO UNACCEPTABLE IMPEDANCES AND A LOSS OF STIMULATION. NO PT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE S8 SURGICAL LEAD SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3244 115548

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention