BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3931735 · Received June 23, 2014

    Report

    Report Number
    1627487-2014-15484
    Event Type
    Injury
    Date Received
    June 23, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 3, 2014
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    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 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: 1627487-2014-15484 IT WAS REPORTED THE PATIENT EXPERIENCES AUTO-REDUCING. THE SJM REPRESENTATIVE MET WITH THE PATIENT AND DIAGNOSTIC TESTING REVEALED INVALID IMPEDANCE READINGS ON MULTIPLE LEAD CONTACTS. REPROGRAMMING WAS UNABLE TO PROVIDE EFFECTIVE COVERAGE. X-RAYS AND A MYELOGRAM WERE TAKEN, HOWEVER THE RESULTS ARE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366806 OCTRODE SCS LEAD GZB ST JUDE MEDICAL - NEUROMODULATION 3186 3923991

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other SCS ANCHOR: MODEL 1192 (2)| IMPLANT DATE:| SCS IPG: MODEL 3788| IMPLANT DATE: