BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3961160 · Received July 15, 2014

    Report

    Report Number
    1627487-2014-21477
    Event Type
    Injury
    Date Received
    July 15, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 19, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION, METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULT: THE DEVICE HISTORY AND STERILIZATION RECORDS 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

    THE PATIENT RECEIVED TWO LEADS WITH THE SAME LOT NUMBER. IT WAS REPORTED THE PATIENT ((B)(6)) WAS HOSPITALIZED DUE TO INCREASED PAIN AT THE LEAD INCISION SITE WHICH WAS DIAGNOSED AS AN INFECTION. AS A RESULT, THE PATIENT'S ENTIRE SCS SYSTEM WAS EXPLANTED. CULTURE RESULTS CONFIRMED STAPHYLOCOCCUS INFECTION. THE PATIENT IS TAKING ORAL ANTIBIOTICS AND HAS BEEN DISCHARGED FROM THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413245 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 4351197

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization SCS IPG: MODEL 3788| SCS ANCHOR: MODEL 1192 (2)| IMPLANT DATE:| IMPLANT DATE: