BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD KIT, 60CM LENGTH

    MDR report key: 2010563 · Received March 1, 2011

    Report

    Report Number
    1627487-2011-00266
    Event Type
    Injury
    Date Received
    March 1, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 1, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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. REFERENCED MFR REPORT# 1627487-2011-00267. THE PT WAS IMPLANTED WITH TWO PERCUTANEOUS LEADS ON (B)(6) 2010. IT WAS REPORTED THAT SHE WAS NOT RECEIVING ADEQUATE THERAPY COVERAGE DUE TO HER ANATOMY. IN AN EFFORT TO RESOLVE THIS MATTER, THE PHYSICIAN REPLACED ONE OF HER LEADS. EFFECTIVE STIMULATION WAS CAPTURED AS A RESULT OF THE PROCEDURE. THE EXPLANTED LEAD WILL NOT BE RETURNED TO THE MANUFACTURER FOR ANALYSIS. IT IS UNK WHICH OF THE PT'S LEADS WAS EXPLANTED; THEREFORE, BOTH LOTS ARE BEING REPORTED.

    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 3213743

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention