BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 2992525 · Received March 4, 2013

    Report

    Report Number
    1627487-2013-05306
    Event Type
    Injury
    Date Received
    March 4, 2013
    Date of Event
    February 7, 2013
    Report Date
    February 7, 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 INFO 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

    ON (B)(6) 2013, THE PT UNDERWENT A TRIAL PROCEDURE. DURING THE PROCEDURE, THE DOCTOR EXPERIENCED DIFFICULTY ATTEMPTING TO IMPLANT THE LEAD DUE TO SCAR TISSUE. AS A RESULT, THE PROCEDURE WAS ABORTED. THE LEAD WAS DISCARDED BY THE SURGICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90725 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3086 3817298

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention