BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 4091833 · Received August 28, 2014

    Report

    Report Number
    1627487-2014-03550
    Event Type
    Injury
    Date Received
    August 28, 2014
    Date of Event
    August 7, 2014
    Report Date
    August 8, 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

    METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE DEVICE HISTORY WAS STERILIZATION RECORDS REVIEWED WERE FOUND TO MEET SPECS 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 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: 1627487-2014-03548 AND 03549. IT WAS REPORTED THE PT EXPERIENCED FEVER, PHOTOSENSITIVITY AND VOMITING. AS A RESULT, THE PT WENT TO THE ER WHERE HIS SCS SYSTEM WAS EXPLANTED DUE TO AN INFECTION AT THE IPG POCKET AND LEAD IMPLANT SITES. IT WAS ALSO REPORTED THE PT WAS ADMITTED TO THE INTENSIVE CARE UNIT WAS RECEIVED ANTIBIOTICS. F/U IDENTIFIED CULTURES REVEALED MRSA AND THE PT IS STILL HOSPITALIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526466 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 4339524

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Hospitalization IMPLANT DATE:| SCS ANCHOR: MODEL 1192 (2)