BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE 44 LEAD KIT, 60CM LENGTH

    MDR report key: 2000762 · Received February 17, 2011

    Report

    Report Number
    1627487-2011-00229
    Event Type
    Injury
    Date Received
    February 17, 2011
    Date of Event
    January 21, 2011
    Report Date
    January 21, 2011
    Manufacturer
    ST JUDE MEDICAL- NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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

    DEVICE 1 OF 2. REFERENCE MFR REPORT # 1627487-2011-00230. THE PT WAS IMPLANTED WITH TWO SURGICAL LEADS ON (B)(6) 2011. DURING A SURGICAL PROCEDURE TO REPLACE HIS IPGS WHICH HAD REACHED THEIR EXPECTED END-OF-LIFE, ONE OF THE LEADS EXHIBITED INVALID IMPEDANCES FOR TWO CONTACTS, AND THE PT ALLEGEDLY FELT NO STIMULATION THROUGH THE LEAD. EFFECTIVE STIMULATION FOR THE PT WAS GENERATED THROUGH THE SECOND LEAD AND THAT DEVICE WAS CONNECTED TO THE NEW IPG. THE NON-FUNCTIONAL LEAD REMAINS IMPLANTED. IT IS UNK FROM WHICH LOT THE DEVICE IN QUESTION ORIGINATED; THEREFORE, BOTH LOTS ARE BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE 44 LEAD KIT, 60CM LENGTH SPINAL CORD STIMULATION LEAD LGW ST JUDE MEDICAL- NEUROMODULATION DIVISION 3244 15858

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention