BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3133291 · Received May 20, 2013

    Report

    Report Number
    1627487-2013-03657
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    April 23, 2013
    Report Date
    April 23, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS REVIEWED WERE FOUND TO MEET SPECIFICATIONS AND NO ANOMALIES RELATED TO THIS EVENT WERE FOUND. CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 1 OF 2. REFERENCE MFR. REPORT: 1627487-2013-03664. THE PATIENT RECEIVED 2 TRIAL SCS LEADS WITH DIFFERENT LOT NUMBERS. THE PATIENT'S SPOUSE REPORTED THE DAY AFTER THE PATIENT UNDERWENT HIS TRIAL PROCEDURE HE BEGAN TO BLEED TO THE POINT THAT HIS CLOTHES AND SHEETS WERE SATURATED. FOLLOW-UP IDENTIFIED THE PATIENT WENT TO THE EMERGENCY ROOM WHERE IT WAS CONFIRMED HE HAD A HIGH WHITE BLOOD COUNT. ADDITIONALLY, IT WAS CLARIFIED THE PATIENT DID NOT EXPERIENCE BLEEDING BUT WAS RELEASING A CLEAR DISCHARGE. MOREOVER, IT WAS CONFIRMED THIS EVENT WAS NOT RELATED TO THE PATIENT'S SCS DEVICE(S) AND THE PATIENT DID NOT HAVE AN INFECTION. FURTHERMORE, THE PATIENT RECEIVED ANTIBIOTICS AND THE ISSUE WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223386 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3086 3890588

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention