BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 2973541 · Received February 19, 2013

    Report

    Report Number
    1627487-2013-13222
    Event Type
    Injury
    Date Received
    February 19, 2013
    Date of Event
    January 22, 2013
    Report Date
    January 22, 2013
    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

    METHOD - THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS - REVIEW OF THE DHR FOUND A NONCONFORMANCE RELATED TO THE PRODUCT LOT. HOWEVER, THE INDIVIDUAL AFFECTED DEVICE WAS REWORKED AND ALL DEVICES WITHIN THE LOT MET ACCEPTANCE CRITERIA. THEREFORE, THE DHR ANOMALY IS NOT RELATED TO THE ALLEGED DEVICE COMPLAINT. 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

    IT WAS REPORTED THE PT WAS EXPERIENCING DISCOMFORT AND ITCHING AT THE TRIAL LEAD INSERTION SITE. THE PT'S PHYSICIAN PRESCRIBED MEDICATION FOR ITCH RELIEF. IT WAS ALSO REPORTED THE PT WAS ADMITTED TO THE HOSP EMERGENCY ROOM FOR SEVERE PAIN AND FEVER. THE PHYSICIAN INDICATED THE PT HAD REDNESS AT THE INSERTION SITE AND A 102 FEVER. THE ER PHYSICIAN OPTED TO EXPLANT THE PT'S LEADS. THE PT WAS ADMITTED TO THE HOSP AND TREATED WITH IV ANTIBIOTICS. FOLLOW-UP INFO IDENTIFIED THE PT WAS RELEASED FROM THE HOSPITAL AND DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72574 OCTRODE SCS LEAD LGW ST JUDE MEDICAL - NEUROMODULATION 3086 3851143

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R