BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD KIT, 60CM LENGTH

    MDR report key: 1990719 · Received February 8, 2011

    Report

    Report Number
    1627487-2011-00173
    Event Type
    Injury
    Date Received
    February 8, 2011
    Date of Event
    January 13, 2011
    Report Date
    January 13, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    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 MFR REPORT# 1627487-2011-00174. THE PT WAS IMPLANTED WITH TWO PERCUTANEOUS LEADS ON (B)(6) 2010. IT WAS REPORTED THAT THE PHYSICIAN REPLACED HER TWO LEADS WITH A SURGICAL ONE ON (B)(6) 2011 DUE TO POSITIONAL STIMULATION PREVIOUSLY EXPERIENCED BY THE PT. IN AN EFFORT TO ALLEVIATE THE REPORTED STIMULATION ISSUE, THE NEW LEAD WAS PLACED AT A DIFFERENT VERTEBRAL LEVEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE LEAD KIT, 60CM LENGTH SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION DIVISION 3186 2825400

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention