BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE PERCUTANEOUS LEAD

    MDR report key: 2212596 · Received August 11, 2011

    Report

    Report Number
    1627487-2011-02924
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    June 14, 2011
    Report Date
    June 14, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: RESULTS: AS RETURNED, THE LEADS WERE CUT. NO FUNCTIONAL TESTING COULD BE PERFORMED. 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 HER SCS SYSTEM ON (B)(6) 2009. IT WAS REPORTED THAT HER PERCUTANEOUS LEAD WERE REPLACED WITH A PADDLE LEAD ON (B)(6) 2011 FOR BETTER COVERAGE. THE PT HAD FALLEN SEVERAL TIMES AND COVERAGE HAD DECLINED. THE EXPLANTED LEADS WERE RETURNED TO THE MFR FOR ANALYSIS. NO ADDITIONAL INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE PERCUTANEOUS LEAD SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 2787308

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention SCS IPG: MODEL 3716| IMPLANT: