BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE PERCUTANEOUS LEAD

    MDR report key: 2003983 · Received February 24, 2011

    Report

    Report Number
    1627487-2011-01164
    Event Type
    Injury
    Date Received
    February 24, 2011
    Date of Event
    January 26, 2011
    Report Date
    January 26, 2011
    Manufacturer
    ST JUDE MEDICAL- NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION WAS NOT PERFORMED AS THE CAUSE OF THE REPORTED COMPLAINT CANNOT BE DETERMINED BY PRODUCT TESTING. METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE FOUND TO MEET SPECIFICATIONS AND NO ANOMALIES WERE FOUND. CONCLUSIONS: 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 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 3. REFERENCE MANUFACTURER REPORTS: 1627487-2011-01163 AND 1627487-2011-01165. THE PT REC'D HER SCS SYSTEM, INCLUDING AN IPG, TWO PERCUTANEOUS LEADS (FROM THE SAME LOT) AND TWO ANCHORS (FROM THE SAME LOT), ON (B)(6) 2010. IT WAS REPORTED THAT THE PT DEVELOPED AN INFECTION AT THE LEAD INSERTION SITE. CONSEQUENTLY, THE PHYSICIAN EXPLANTED THE PT'S SYSTEM; HOWEVER, THE EXPLANT DATE IS CURRENTLY UNDETERMINED. THE EXPLANTED SYSTEM WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. IT WAS REPORTED THAT THE PT WAS TREATED WITH ORAL AND INTRAVENOUS ANTIBIOTICS. A CULTURE WAS ALLEGEDLY TAKEN, BUT THE RESULTS ARE UNK. THE PHYSICIAN STATED THAT HE THOUGHT THE CAUSE OF THE INFECTION WAS NOT PRODUCT RELATED. F/U ON THE PT FOUND NO FURTHER ISSUES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE PERCUTANEOUS LEAD SPINAL CORD STIMULATION LEAD LGW ST JUDE MEDICAL- NEUROMODULATION DIVISION 3186 2861857

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R