BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 4113012 · Received September 17, 2014

    Report

    Report Number
    1627487-2014-25614
    Event Type
    Injury
    Date Received
    September 17, 2014
    Date of Event
    August 27, 2014
    Report Date
    August 27, 2014
    Manufacturer
    ST JUDE MED - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFORMATION RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING THE PT'S (B)(6) PERMANENT PROCEDURE THE PHYSICIAN TESTED THE PT'S TRIAL LEAD WHICH REVEALED INVALID IMPEDANCE MEASUREMENTS. IN TURN, THE PHYSICIAN EXPLANTED THE LEAD AND ABANDONED THE PROCEDURE. ADDITIONALLY, IT WAS REPORTED THE PHYSICIAN EXPERIENCED DIFFICULTY REMOVING THE LEAD DUE TO SCAR TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    574283 OCTRODE SCS LEAD GZB ST JUDE MED - NEUROMODULATION 3186 4291506

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other