BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 2792121 · Received October 11, 2012

    Report

    Report Number
    1627487-2012-02479
    Event Type
    Injury
    Date Received
    October 11, 2012
    Date of Event
    September 18, 2012
    Report Date
    September 18, 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 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

    DEVICE 2 OF 3. REFERENCE MFR REPORTS: 16247487-2012-02478 AND 02480. IT WAS REPORTED THE PT'S LEADS HAD MIGRATED. THE PHYSICIAN EXPLANTED AND REPLACED THE LEADS WITH A SURGICAL LEAD. IT WAS ALSO REPORTED THE PT EXPERIENCES DISCOMFORT AT HER IPG SITE OVER THE LEFT UPPER BUTTOCK REGION. ALLEGEDLY THE PHYSICIAN OFFERED TO REPOSITION THE IPG DURING THE LEAD PROCEDURE BUT THE PT DECLINED. IT WAS REPORTED SHE WILL CONTACT THE PHYSICIAN WHEN READY TO MOVE FORWARD WITH THE IPG REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3382913

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention SCS ANCHOR: MODEL 1192 (2)| IMPLANT DATE: