BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 2792060 · Received October 12, 2012

    Report

    Report Number
    1627487-2012-11483
    Event Type
    Injury
    Date Received
    October 12, 2012
    Date of Event
    September 19, 2012
    Report Date
    September 19, 2012
    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

    IT WAS REPORTED THE PHYSICIAN WAS PERFORMING A PROCEDURE UNRELATED TO THE SCS SYSTEM AND DAMAGED THE LEAD. THE PHYSICIAN OPTED TO REPLACE THE LEAD DURING THE PROCEDURE. IT WAS REPORTED THE PRODUCT WAS DISCARDED. FOLLOW UP IDENTIFIED THE PT RECEIVED STIMULATION COVERAGE POSTOPERATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 29493

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention