BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 4252862 · Received November 11, 2014

    Report

    Report Number
    1627487-2014-26951
    Event Type
    Injury
    Date Received
    November 11, 2014
    Date of Event
    August 19, 2014
    Report Date
    October 22, 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 AN 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

    THE PATIENT IS IMPLANTED WITH A SCS SYSTEM WHICH INCLUDES TWO LEADS FROM THE SAME LOT. IT WAS REPORTED THE PATIENT IS NOT RECEIVING EFFECTIVE STIMULATION. LEAD DIAGNOSTICS SHOWED MULTIPLE INVALID CONTACTS. SURGICAL INTERVENTION IS PENDING TO ADDRESS THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726451 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3189 2881613

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other IMPLANT DATE:| SCS ANCHOR: MODEL 1194 (2)| IMPLANT DATE:| SCS IPG: MODEL 3788