BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3931769 · Received June 23, 2014

    Report

    Report Number
    1627487-2014-26523
    Event Type
    Injury
    Date Received
    June 23, 2014
    Date of Event
    April 29, 2014
    Report Date
    June 2, 2014
    Manufacturer
    ST JUDE MEDICAL NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    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 #2 OF 2 REFERENCE MFR. REPORT: 1627487-2014-26522 IT WAS REPORTED THE PATIENT WAS EXPERIENCING AUTO-REDUCING. THE SJM REPRESENTATIVE MET WITH THE PATIENT AND LEAD DIAGNOSTICS SHOWED AUTO-REDUCING WAS OCCURRING ON LEAD 9-15 AND IMPEDANCES WERE HIGH. REPROGRAMMING WAS ABLE TO RESOLVE THE ISSUE. THE PATIENT IS NOW RECEIVING EFFECTIVE STIMULATION. FOLLOW UP INFORMATION IDENTIFIED THE PATIENT FEELS BETTER WITHOUT THE STIMULATION AND SURGICAL INTERVENTION MAY BE PENDING TO REMOVE THE SCS SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366828 OCTRODE SCS LEAD GZB ST JUDE MEDICAL NEUROMODULATION 3186 4131100

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR SCS ANCHOR: MODEL 1192(2)| IMPLANT DATE:| SCS IPG: MODEL 3788| IMPLANT DATE: