BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD KIT, 60CM LENGTH

    MDR report key: 1980305 · Received February 2, 2011

    Report

    Report Number
    1627487-2011-00143
    Event Type
    Injury
    Date Received
    February 2, 2011
    Date of Event
    January 5, 2011
    Report Date
    January 5, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    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 # 1627487-2011-00144. THE PT RECEIVED HIS SCS SYSTEM ON (B)(6) 2009 INCLUDING TWO PERCUTANEOUS LEADS; ONE OF WHICH WAS PLACED PERIPHERALLY (OFF-LABEL INDICATION). IT WAS REPORTED THAT THE PT LOST STIMULATION. THE PT HAD REPORTED HE DID SOME ACTIVITY THAT MAY HAVE CONTRIBUTED TO THE ALLEGED LEAD MIGRATION. AN X-RAY CONFIRMED THAT BOTH OF HIS LEADS HAD MIGRATED. SURGICAL INTERVENTION WAS UNDERTAKEN TO REPLACE THE LEADS AND EFFECTIVE STIMULATION WAS RECAPTURED FOR THE PT AS A RESULT. THE EXPLANTED DEVICES WILL NOT BE RETURNED TO THE MFR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE LEAD KIT, 60CM LENGTH SPINAL CORD STIMULATION LEAD LGW ST JUDE MEDICAL - NEUROMODULATION DIVISION 3186 2787308

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention