BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE 88 SURGICAL LEAD

    MDR report key: 2133624 · Received June 16, 2011

    Report

    Report Number
    1627487-2011-01666
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    May 20, 2011
    Report Date
    May 20, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: AS RECEIVED, THE LAMITRODE WAS CUT; THEREFORE, NO FUNCTIONAL TESTING COULD BE PERFORMED ON THE LEAD. 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 1 OF 2. REFERENCE MANUFACTURER REPORT: 1627487-2011-01667. THE PATIENT (B)(6) RECEIVED AN SCS SYSTEM, INCLUDING A SURGICAL LEAD AND TWO EXTENSIONS (FROM THE SAME LOT). IT WAS REPORTED THAT THE PATIENT'S LEAD WAS FRACTURED, AND CONSEQUENTLY THE PATIENT LOST STIMULATION. DIAGNOSTIC TESTS EXHIBITED INVALID IMPEDANCE READINGS ON MULTIPLE LEAD CONTACTS. INTRAOPERATIVE TESTING ON THE LEAD AND EXTENSIONS YIELDED THE SAME IMPEDANCE ISSUES. THE PHYSICIAN EXPLANTED AND REPLACED THE LEAD AND EXTENSIONS ON (B)(6) 2011. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE 88 SURGICAL LEAD SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3288 2887701

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention