BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE PERCUTANEOUS LEAD

    MDR report key: 1990067 · Received February 8, 2011

    Report

    Report Number
    1627487-2011-01128
    Event Type
    Injury
    Date Received
    February 8, 2011
    Date of Event
    January 14, 2011
    Report Date
    January 14, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIV
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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

    DEVICE 2 OF 2. REFERENCE MFR REPORT: 1627487-2011-01127. THE PT RECEIVED HER SCS SYS, INCLUDING AN IPG AND TWO PERCUTANEOUS LEADS (FROM TWO SEPARATE LOTS), ON (B)(6) 2010. IT WAS REPORTED THAT THE PT LOST STIMULATION; SHE WAS UNABLE TO TURN THE STIMULATION UP TO PERCEPTION. DIAGNOSTIC IMPEDANCE TESTS SHOWED THAT ALL LEAD CONTACTS REVEALED HIGH IMPEDANCE READINGS. THE PT REPORTED SHE HAD NOT HAD ANY TRAUMATIC EVENTS SINCE THE IMPLANT DATE. F/U ON THE PT FOUND THAT THE PHYSICIAN PLANNED TO REPLACE THE PT'S LEADS ON (B)(6) 2011. HOWEVER, IT WAS REPORTED THAT DUE TO SCAR TISSUE, THE PHYSICIAN WAS UNABLE TO INSERT THE NEW LEADS WHERE NEEDED. THE PHYSICIAN DECIDED TO EXPLANT THE PT'S SYS. THE EXPLANTED LEADS WERE RETURNED TO THE MFR FOR ANALYSIS ON (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE PERCUTANEOUS LEAD SPINAL CORD STIMULATION LEAD LGW ST JUDE MEDICAL - NEUROMODULATION DIV 3186 3097023

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention