BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3192071 · Received June 20, 2013

    Report

    Report Number
    1627487-2013-02865
    Event Type
    Injury
    Date Received
    June 20, 2013
    Date of Event
    May 29, 2013
    Report Date
    May 29, 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 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

    THE PATIENT WAS IMPLANTED WITH 2 LEADS FROM THE SAME LOT. IT WAS REPORTED THE PATIENT COMPLAINED OF INEFFECTIVE STIMULATION COVERAGE. REPROGRAMMING WAS UNABLE TO RESOLVE THE ISSUE. AN X-RAY SHOWED THE LEADS HAD MIGRATED. THE PHYSICIAN EXPLANTED AND REPLACED THE LEADS ON (B)(6) 2013, AND THE PATIENT REPORTED EFFECTIVE STIMULATION COVERAGE POSTOPERATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281060 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL NEUROMODULATION 3186 3646409

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Other SCS ANCHOR: MODEL 1192 (2)| SCS IPG: MODEL 3688| IMPLANT DATE:| IMPLANT DATE: