BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3111394 · Received May 2, 2013

    Report

    Report Number
    1627487-2013-03594
    Event Type
    Injury
    Date Received
    May 2, 2013
    Date of Event
    November 7, 2012
    Report Date
    March 20, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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 PT WAS UNABLE TO TURN ON SYSTEM STIMULATION DUE TO AUTOREDUCTION. CHANGING PROGRAMS DID NOT RESOLVE THE ISSUE. FOLLOW-UP IDENTIFIED THE PT'S SCS LEAD WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193391 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 2784330

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention SCS EXTENSION: MODEL 3382| IMPLANTED:| SCS IPG: MODEL 3716| IMPLANTED: