BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE PERCUTANEOUS LEAD

    MDR report key: 1936223 · Received December 14, 2010

    Report

    Report Number
    1627487-2010-03433
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    November 16, 2010
    Report Date
    November 16, 2010
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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: 1627487-2010-03434. THE PT RECEIVED HIS SCS SYSTEM, CONSISTING OF AN IPG AND TWO PERCUTANEOUS LEADS (FROM TWO SEPARATE LOTS), ON (B)(6) 2010, FOR LEFT LEG AND LOW BACK PAIN. IT WAS REPORTED THAT THE PT LOST STIMULATION TO HIS LEFT SIDE. A FLUOROSCOPY SHOWED THE LEFT LEAD HAD MIGRATED RIGHT OF MIDLINE AND SUPERIORLY BY ONE VERTEBRAL BODY. THE RIGHT LEAD HAD NOT MOVED. REPROGRAMMING EFFORTS WERE UNSUCCESSFUL IN RESOLVING THE ISSUE. F/U ON THE PT FOUND THAT THE PHYSICIAN PLANS TO REFER THE PT TO EXPLANT HIS PERCUTANEOUS LEADS AND REPLACE THEM WITH A PADDLE LEAD. THE PROCEDURE DATE IS CURRENTLY UNDETERMINED. NO FURTHER 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 DIVISION 3186 3071334

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention