BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE PERCUTANEOUS LEAD

    MDR report key: 2000817 · Received February 17, 2011

    Report

    Report Number
    1627487-2011-01159
    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
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    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

    THE PT REC'D AN SCS SYSTEM, INCLUDING AN IPG AND TWO PERCUTANEOUS LEADS (FROM THE SAME LOT), ON (B)(6) 2010, FOR LOW BACK AND LEG PAIN. IT WAS REPORTED THAT THE PT WAS HAVING A CONTINUED ACHE IN THE UPPER RIGHT PORTION OF HER ABDOMEN. AN X-RAY REVEALED THAT ONE OF THE LEADS HAD MIGRATED ANTERIORLY. THE PHYSICIAN EXPLANTED THE LEADS AND REPLACED THEM WITH ONE LEAD ON (B)(6) 2011. THE EXPLANTED LEADS WERE RETURNED TO THE MFR FOR ANALYSIS. F/U ON THE PT FOUND NO FURTHER ISSUES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE PERCUTANEOUS LEAD SPINAL CORD STIMULATION LEAD LGW ST JUDE MEDICAL - NEUROMODULATION DIVISION 3186 3194952

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention