BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3001547 · Received March 5, 2013

    Report

    Report Number
    1627487-2013-12319
    Event Type
    Injury
    Date Received
    March 5, 2013
    Date of Event
    February 14, 2013
    Report Date
    February 14, 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 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'S COVERAGE ON THE LEFT SIDE IS EFFECTIVE, HOWEVER THE COVERAGE ON THE RIGHT SIDE IS INEFFECTIVE. X-RAYS REVEALED THE RIGHT LEAD HAS MIGRATED. THE PHYSICIAN PLANS SURGICAL INTERVENTION TO ADDRESS THE ISSUE. NOTE THE PT REC'D TWO LEADS FROM THE SAME LOT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94102 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3892148

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention IMPLANT DATE:| SCS ANCHORS: MODEL 1192 (2)| IMPLANT DATE:| SCS IPG: MODEL 3788