BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3012168 · Received March 13, 2013

    Report

    Report Number
    1627487-2013-13288
    Event Type
    Injury
    Date Received
    March 13, 2013
    Date of Event
    February 20, 2013
    Report Date
    February 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
    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 2. REFERENCE MFR. REPORT: 1627487-2013-13289. THE PT HAS TWO LEADS FROM TWO DIFFERENT LOT NUMBERS, REPORTING ON BOTH LEADS. IT WAS REPORTED THE PT WAS NO LONGER RECEIVING EFFECTIVE STIMULATION TO COVER HER PAIN AREA. THE PT HAS A BRAIN TUMOR AND IS CONSIDERING HAVING HER SCS SYSTEM EXPLANTED IN ORDER TO HAVE AN MRI. FOLLOW-UP PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106499 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 172804

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention SCS IPG: MODEL: 3788| IMPLANT DATE: