BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 2831679 · Received November 9, 2012

    Report

    Report Number
    1627487-2012-06729
    Event Type
    Injury
    Date Received
    November 9, 2012
    Date of Event
    October 10, 2012
    Report Date
    October 17, 2012
    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 3 OF 3. REFERENCE MFR. REPORT # 1627487-2012-06727, 06728. THE PT HAD AN SCS SYSTEM FOR OFF-LABEL USE. IT WAS REPORTED THE PT WAS ADMITTED TO THE HOSPITAL. CULTURE RESULTS REVEALED A STAPH INFECTION AT THE IPG AND LEAD SITE. AS A RESULT, THE PT'S SCS SYSTEM WAS EXPLANTED. THE EXPLANTED PRODUCT WAS DISCARDED BY THE SURGICAL FACILITY. THE PT WAS GIVEN IV AND ORAL ANTIBIOTICS TO TREAT THE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3700979

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R