BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3193661 · Received June 25, 2013

    Report

    Report Number
    1627487-2013-06522
    Event Type
    Injury
    Date Received
    June 25, 2013
    Date of Event
    May 31, 2013
    Report Date
    May 31, 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

    EVALUATION CODES: 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 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 2 OF 2. REFERENCE MFR REPORT: 1627487-2013-06521. IT WAS REPORTED THE PT WENT TO THE ER DUE TO AN INFECTION. THE PHYSICIAN DECIDED TO EXPLANT THE PT'S SCS SYSTEM AND AN ACTIVE INFECTION WAS FOUND AT BOTH THE IPG AND THE LEAD SITES. CULTURES AT THE INFECTION SITES WERE (B)(6) FOR (B)(6) INFECTION. BLOOD CULTURES WERE NEGATIVE, AND AN MRI WAS TAKEN AND NO ANOMALIES WERE NOTED. THE PT WAS TREATED WITH INTRAVENOUS ANTIBIOTICS VIA A PICC LINE. THE PT WAS DISCHARGED FROM THE HOSPITAL BUT RETURNED TWO DAYS LATER WITH A SUSPECTED EPIDURAL ABSCESS. A FOLLOW UP MRI WAS TAKEN BUT IT DID NOT SHOW ANY ANOMALIES. FOLLOW-UP IDENTIFIED THE PT CONTINUES TREATMENT WITH INTRAVENOUS ANTIBIOTICS AT HOME AND IS DOING WELL AND THE WOUNDS ARE HEALING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289325 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3816524

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Hospitalization IMPLANTED:| SCS ANCHOR: MODEL 1192