BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE PERCUTANEOUS LEAD

    MDR report key: 2000854 · Received February 17, 2011

    Report

    Report Number
    1627487-2011-01140
    Event Type
    Injury
    Date Received
    February 17, 2011
    Date of Event
    January 19, 2011
    Report Date
    January 19, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: REVIEW OF THE DEVICE HISTORY RECORDS FOUND A NONCONFORMANCE; HOWEVER, THE NONCONFORMANCE WAS IDENTIFIED AS A COSMETIC ISSUE AND PRODUCT WAS REPLACED AND RELEASED FOR USE. THE DHR ANOMALY IS NOT RELATED TO THE ALLEGED DEVICE FAILURE. 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 1 OF 2. REFERENCE MFR REPORT: 1627487-2011-01141. THE PT HAD TWO PERCUTANEOUS LEADS (FROM THE SAME LOT) IMPLANTED ON (B)(6) 2000 AND ONE PERCUTANEOUS LEAD LATER IMPLANTED ON (B)(6) 2009 AS PART OF HER SCS SYSTEM. IT WAS REPORTED THAT THE LEADS WERE ERODING THROUGH THE PT'S SKIN. THE PHYSICIAN DECIDED TO EXPLANT THE LEADS ON (B)(6) 2011. THE EXPLANTED LEADS WERE DISCARDED BY HOSPITAL PERSONNEL AND WILL NOT BE RETURNED TO THE MFR FOR ANALYSIS. F/U ON THE PT FOUND THAT THE PT RECEIVED ANTIBIOTIC THERAPY AND WAS REPORTED AS DOING WELL. NO FURTHER ISSUES HAVE BEEN REPORTED FROM THIS PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE PERCUTANEOUS LEAD SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 173791

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention