BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3182153 · Received June 14, 2013

    Report

    Report Number
    1627487-2013-05858
    Event Type
    Injury
    Date Received
    June 14, 2013
    Date of Event
    May 21, 2013
    Report Date
    May 21, 2013
    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 HAD TWO LEADS FROM THE SAME LOT. IT WAS REPORTED ONE OF THE LEADS HAD MIGRATED AND WAS CAUSING THE PT DISCOMFORT. AS A RESULT, THE PT UNDERWENT SURGICAL INTERVENTION. DURING THE PROCEDURE THE DOCTOR CUT AND EXPLANTED THE MIGRATED LEAD. THE DOCTOR IS AWARE OF THE RISK ASSOCIATED FOR CUTTING THE LEAD. THE OTHER LEAD REMAINS IMPLANTED. THE ISSUE IS RESOLVED AND THE PT IS DOING WELL. THE EXPLANTED PRODUCT WILL NOT BE RETURNED TO SJM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271691 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3181 2850523

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other SCS IPG, MODEL 3788| IMPLANT DATE:| SCS ANCHORS, MODEL 1194 (X2)| IMPLANT DATE: