BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3960212 · Received July 23, 2014

    Report

    Report Number
    1627487-2014-15561
    Event Type
    Injury
    Date Received
    July 23, 2014
    Date of Event
    June 17, 2014
    Report Date
    July 1, 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 AND 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 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 2 OF 2. REF MFR REPORT: 1627487-2014-15560. THE PT UNDERWENT A PROCEDURE FOR A TRIAL SCS SYSTEM ON 01/01/2014 AND APPROX 6 DAYS LATER, THE PT EXPERIENCED PAIN AND WENT TO THE EMERGENCY ROOM. IT WAS DETERMINED THE PT HAD AN ABSCESS. THE LOCATION OF THE ABSCESS WAS NOT PROVIDED AND IT IS UNK IF CULTURES WERE TAKEN. THE PT WAS PLACED ON IV ANTIBIOTICS AND THE ABSCESS HAS SINCE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429806 OCTRODE SCS LEAD GZB ST JUDE MEDICAL - NEUROMODULATION 3086 4519013

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization