BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE 8 PERCUTANEOUS LEAD

    MDR report key: 1944711 · Received December 15, 2010

    Report

    Report Number
    1627487-2010-02749
    Event Type
    Injury
    Date Received
    December 15, 2010
    Date of Event
    August 23, 2010
    Report Date
    August 23, 2010
    Manufacturer
    ST JUDE MEDICAL -NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL METHOD: DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED AND WERE FOUND TO MEET SPECS AND NO ANOMALIES WERE FOUND. CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. THIS MDR IS BEING SUBMITTED PAST THE 30 DAY REPORTING REQUIREMENT AS PART OF A RETROSPECTIVE REVIEW INITIATED IN RESPONSE TO AN FDA INSPECTION. WE ARE SUBMITTING THIS MDR AS THE RESULT OF A RE-EVALUATION OF OUR MDR REVIEW PROCESS. 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 1 OF 4. REFERENCE MFR REPORTS: 1627487-2010-04088, 1627487-2010-04089 AND 1627487-2010-04090. THE PT RECEIVED HIS SCS SYSTEM, INCLUDING AN IPG, TWO PERCUTANEOUS LEADS (OF THE SAME LOT) AND TWO ANCHORS. IT WAS REPORTED THE SYSTEM WAS EXPLANTED AND REPLACED DUE TO AN INFECTION. A CULTURE OF THE INFECTED SITE CONFIRMED A (B)(6). THE PT WAS ADMITTED TO THE HOSPITAL AND ANTIBIOTICS WERE DELIVERED INTRAVENOUSLY. THE EXPLANTED PRODUCTS WERE NOT RETURNED TO THE MFR FOR ANALYSIS. NO FURTHER PT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE 8 PERCUTANEOUS LEAD SPINAL CORD STIMULATION LEAD LGW ST JUDE MEDICAL -NEUROMODULATION 3189 3143270

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R