BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD, 30CM LENGTH

    MDR report key: 2103733 · Received May 24, 2011

    Report

    Report Number
    1627487-2011-00714
    Event Type
    Injury
    Date Received
    May 24, 2011
    Date of Event
    April 25, 2011
    Report Date
    April 25, 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

    SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE PT, AN EXISTING SCS SYSTEM USER, UNDERWENT A STAGED TRIAL WITH A PERCUTANEOUS LEAD AND AN EXTERNALIZED EXTENSION FOR LOW BACK AND BILATERAL LEG PAIN. IT WAS REPORTED THAT AS THE TRIAL PERIOD PROGRESSED, THE PT BEGAN TO FEEL SHARP AND PAINFUL SENSATIONS IN HIS RIGHT RIB. THE REPORTED DISCOMFORT WAS SAID TO BE PRESENT WITH ALL THE PT'S SET PROGRAMS. F/U ON THIS MATTER FOUND THAT THE TRIAL ENDED ON (B)(6) 2011, AT WHICH TIME, THE LEAD WAS EXPLANTED. THE PT WILL BE REFERRED TO A PHYSICIAN FOR PADDLE LEAD PLACEMENT. NO FURTHER COMPLICATIONS WERE REPORTED. THE EXPLAINED LEAD WAS RETAINED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE LEAD, 30CM LENGTH SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3183 3229444

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention SCS LEAD EXTENSION: MODEL 3383| IMPLANT:| SCS LEAD EXTENSION: MODEL 3383| IMPLANT:| USED AS AN EXTERNAL DEVICE DURING STAGE TRIAL| SCS IPG: MODEL 3716