BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3133327 · Received May 20, 2013

    Report

    Report Number
    1627487-2013-05713
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    April 24, 2013
    Report Date
    April 24, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    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 2 OF 2. REFERENCE MFR. REPORT#: 1627487-2013-05712. THE PATIENT HAD TWO LEADS FROM THE SAME LOT. IT WAS REPORTED THE PATIENT'S RECEIVER WAS EXPLANTED AND REPLACED (WITH AN IPG) DUE TO BEING NON-FUNCTIONAL. THE PATIENT'S LEADS WERE EXPLANTED AND REPLACED (WITH A SINGLE LEAD/DIFFERENT MODEL) DUE TO MIGRATING. THE PATIENT'S ISSUES ARE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223332 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 34024

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention