BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3052632 · Received April 2, 2013

    Report

    Report Number
    1627487-2013-02464
    Event Type
    Injury
    Date Received
    April 2, 2013
    Date of Event
    October 1, 2012
    Report Date
    February 4, 2013
    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

    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. REF MFR REPORT: 1627487-2013-02465. THE PT RECEIVED TWO LEADS FROM THE SAME LOT AS PART OF HIS SCS SYSTEM (DEVICE 1). IT WAS REPORTED THE PT WAS NO LONGER ABLE TO FEEL STIMULATION IN HIS PAIN AREA. F/U IDENTIFIED THE LEADS HAD MIGRATED. THE PT UNDERWENT SURGERY ON (B)(6) 2013 TO REPLACE THE LEADS. DURING THE PROCEDURE, THE LEADS WERE EXPLANTED BUT THE PHYSICIAN WAS UNABLE TO IMPLANT NEW LEADS (DEVICE 2) DUE TO SCAR TISSUE. THE PROCEDURE ALLEGEDLY WAS ABANDONED AND THE PT WAS REFERRED TO A SURGEON FOR A PADDLE LEAD PLACEMENT. ADDITIONAL F/U INDICATED THE PT RECEIVED A PADDLE LEAD ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133812 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 86426

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention IMPLANT DATE:| SCS IPG: MODEL 3716