BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 2893006 · Received December 28, 2012

    Report

    Report Number
    1627487-2012-13317
    Event Type
    Injury
    Date Received
    December 28, 2012
    Date of Event
    October 22, 2012
    Report Date
    October 22, 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 PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    REFERENCE MFR. REPORT: 1627487-2012-13316. THE PATIENT HAD TWO LEADS FROM DIFFERENT LOT NUMBERS, BOTH LEADS ARE BEING REPORTED. IT WAS REPORTED THE PATIENT UNDERWENT A SUCCESSFUL TRIAL PROCEDURE. A FEW DAYS AFTER THE TRIAL PROCEDURE, IT WAS REPORTED THE PATIENT HAD SYMPTOMS OF A STROKE. THE TRIAL WAS ABORTED. FOLLOW-UP INFORMATION IDENTIFIED THE PATIENT HAD AN ACUTE STROKE NOT RELATED TO THE TRIAL PROCEDURE. A CT SCAN CONFIRMED THE PATIENT HAD A STROKE. THE PATIENT'S SYMPTOMS HAVE NOT RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3183 3365363

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention SCS EXTENSION: MODEL 3386 (2)| SCS ANCHOR: MODEL 1192 (2)| IMPLANT DATE:| IMPLANT DATE: