BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 2792136 · Received October 11, 2012

    Report

    Report Number
    1627487-2012-03521
    Event Type
    Injury
    Date Received
    October 11, 2012
    Date of Event
    September 13, 2012
    Report Date
    September 13, 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 1 OF 3. REFERENCE MFR REPORTS: 1627487-2012-03522 AND 03523. THE PT REC'D 2 SCS LEADS ON (B)(6) 2012 WITH THE SAME LOT NUMBER AND 2 SCS LEADS ON (B)(6) 2012 WITH DIFFERENT LOT NUMBERS. IT WAS REPORTED ONE OF THE SCS LEADS MIGRATED. BOTH SCS LEADS WERE EXPLANTED. AFTER THE SCS LEADS WERE EXPLANTED THE PHYSICIAN HAD DIFFICULTY STEERING THE REPLACEMENT SCS LEADS AND DECIDED NOT TO COMPLETE THE PROCEDURE. THE SURGICAL PROCEDURE WAS EXTENDED BY APPROX 1 HR. SURGICAL INTERVENTION WILL BE TAKEN AT A LATER DATE TO REPLACE THE ORIGINAL SCS LEADS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3597334

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention SCS IPG: MODEL 3716| SCS ANCHOR: MODEL 1192 (2)| IMPLANT DATE:| IMPLANT DATE: