BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 2881452 · Received December 17, 2012

    Report

    Report Number
    1627487-2012-14201
    Event Type
    Injury
    Date Received
    December 17, 2012
    Date of Event
    February 9, 2012
    Report Date
    February 9, 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

    DEVICE 1 OF 3. REFERENCE MFR REPORTS: 1627487-2012-14202 AND 1627487-2012-14203. THE PATIENT HAD TWO LEADS IMPLANTED WITH THE SAME LOT NUMBER. IT WAS REPORTED THE PATIENT WAS NO LONGER RECEIVING EFFECTIVE STIMULATION. THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2012 TO REPLACE HIS LEADS. THE PHYSICIAN REMOVED THE PATIENT'S LEADS AND ATTEMPTED TO IMPLANT NEW LEADS. THE PHYSICIAN WAS UNABLE TO ACCESS THE EPIDURAL SPACE, AND COULD NOT ADVANCE THE LEAD DUE TO STENOSIS (REFERENCE MFR REPORT: 1627487-2012-11850). REVISION WAS ABORTED. THE PATIENT WAS REFERRED TO A NEUROSURGEON FOR A POSSIBLE PADDLE LEAD PLACEMENT. THE PATIENT'S IPG REMAINS IMPLANTED. SURGICAL INTERVENTION IS PENDING TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3183 3153778

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention SCS IPG, MODEL 3788| IMPLANT DATE:| SCS ANCHOR, MODEL 1192 (2)| IMPLANT DATE: