BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3133370 · Received May 20, 2013

    Report

    Report Number
    1627487-2013-05703
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    April 23, 2013
    Report Date
    April 24, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    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

    DEVICE 1 OF 2. REFERENCE MFR REPORT#: 1627487-2013-05704. THE PT HAD TWO TRIAL LEADS. IT WAS REPORTED, THE PT WENT TO THE EMERGENCY ROOM DUE TO PAIN AT THE LEAD SITE. AN INFECTION WAS FOUND AND THE LEADS WERE REMOVED. AN SJM REP PLANS TO VERIFY IF AN INFECTION WAS PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223503 OCTRODE UNK LGW ST. JUDE MEDICAL - NEUROMODULATION 3086 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R