BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD KIT, 90CM LENGTH

    MDR report key: 2042081 · Received March 31, 2011

    Report

    Report Number
    1627487-2011-00444
    Event Type
    Injury
    Date Received
    March 31, 2011
    Date of Event
    March 2, 2011
    Report Date
    March 2, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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

    THE PT RECEIVED AN SCS SYSTEM ON (B)(6) 2010, INCLUDING TWO PERCUTANEOUS LEADS PLACED IN THE OCCIPITAL REGION FOR HEADACHES (OFF-LABEL INDICATION). IT WAS REPORTED THAT THE LEADS WERE REPLACED DUE TO MIGRATION AS THE PT REPORTEDLY FELT STIMULATION IN HIS RIBS. THE EXPLANTED DEVICES WERE DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE LEAD KIT, 90CM LENGTH SPINAL CORD STIMULATION LEAD LGW ST JUDE MEDICAL - NEUROMODULATION DIVISION 3189 3250359

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention SCS IPG: MODEL 3788| IMPLANT: