BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE PERCUTANEOUS LEAD

    MDR report key: 1990639 · Received February 8, 2011

    Report

    Report Number
    1627487-2011-01131
    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
    WV, 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 1 OF 2. REFERENCE MFR REPORT: 1627487-2011-01132. THE PT RECEIVED HER SCS SYS, INCLUDING TWO PERCUTANEOUS LEADS (FROM TWO SEPARATE LOTS) AND AN IPG, ON (B)(6) 2006. IT WAS REPORTED THAT ALL LEAD CONTACTS EXHIBITED HIGH OR INVALID IMPEDANCE READINGS. THE PT STATED THAT THE INSULIN HAD SLOWLY FADED OVER TIME, AND OVER THE LAST MONTH THE STIMULATION CEASED. THE PHYSICIAN EXPLANTED AND REPLACED THE LEADS WITH ONE SMALLER MODEL LEAD ON (B)(6) 2011. THE PHYSICIAN NOTED THAT THE PT HAD A LOT OF SCARRING IN HER EPIDURAL SPACE FROM THE PERCUTANEOUS LEADS. IT WAS REPORTED THAT THE PHYSICIAN CUT THE LEADS DURING THE REMOVAL PROCESS. AS A RESULT OF THE REPLACEMENT PROCEDURE, THE PT REPORTED EFFECTIVE STIMULATION. 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 57474

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention