BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3875164 · Received May 22, 2014

    Report

    Report Number
    1627487-2014-26503
    Event Type
    Injury
    Date Received
    May 22, 2014
    Date of Event
    April 21, 2014
    Report Date
    April 28, 2014
    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

    THE PT UNDERWENT A TRIAL PROCEDURE WHICH INCLUDED TWO TRIAL LEADS FROM THE SAME LOT. IT WAS REPORTED THE PT EXPERIENCED PAIN AND A BURNING SENSATION IN HER RIGHT SHOULDER. THE PT WAS IMPLANTED WITH A CERVICAL TRIAL LEAD ON (B)(6) 2014 AND DID NOT REPORT ANY ISSUES PRIOR TO THE END OF TRIAL; HENCE, THE TRIAL WAS CONSIDERED SUCCESSFUL. DURING THE TRIAL LEAD REMOVAL, THE PT REPORTED EXPERIENCING THE AFOREMENTIONED SYMPTOMS, STATING THEY BEGAN THE LAST FEW DAYS OF THE TRIAL AND HAVE NOT RESOLVED. THE PHYSICIAN BELIEVES THE SYMPTOMS ARE RELATED TO ALLODYNIA OR NERVE ROOT IRRITATION AND PRESCRIBED A MEDROL DOSE PACK TO ADDRESS THE REPORTED ISSUE. FOLLOW UP INFO IDENTIFIED THE PRESCRIBED MEDICATION HELPED THE PT'S PAIN AND THE ISSUES HAS BEEN RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304573 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3086 4509737

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other