BEUDAMED
    FDA Adverse Event Death Summary report: N

    OCTRODE PERCUTANEOUS LEAD

    MDR report key: 1674012 · Received April 30, 2010

    Report

    Report Number
    1627487-2010-00413
    Event Type
    Death
    Date Received
    April 30, 2010
    Date of Event
    April 7, 2009
    Report Date
    January 27, 2009
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    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: DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS REVIEWED WERE FOUND TO MEET SPECIFICATIONS 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 A RESPONSE TO AN FDA INSPECTION. A RETROSPECTIVE REVIEW OF THE COMPLAINT RECORD DETERMINED THAT ANS MISINTERPRETED THE MDR REGULATIONS IN THIS INSTANCE. ANS HAS LIMITED INFORMATION 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. ANS DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE PATIENT RECEIVED HER SCS SYSTEM CONSISTING OF AN IPG AND TWO PERCUTANEOUS LEADS ON (B) (6) 2008. IT WAS REPORTED THAT THE FOLLOWING DAY THE PATIENT WENT TO THE EMERGENCY ROOM WHERE SHE WAS DIAGNOSED WITH A SUBDURAL HEMATOMA AND WAS ADMITTED TO THE HOSPITAL. IT WAS REPORTED THAT THE PATIENT WAS STILL IN THE HOSPITAL ON (B) (6) 2009, WHEN SHE SUFFERED A HEART ATTACK AND DIED. NO DEVICES WERE EXPLANTED FROM THE PATIENT, THEREFORE, NONE WERE RETURNED TO ANS FOR EVALUATION. ANS MADE NUMEROUS ATTEMPTS TO LOCATE THE PHYSICIAN'S OFFICE FOR ADDITIONAL INFORMATION, BUT WAS NOT SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE PERCUTANEOUS LEAD SPINAL CORD STIMULATION LEAD LGW ADVANCED NEUROMODULATION SYSTEMS 3189 175098

    Patients

    Seq Age Sex Outcome Treatment
    1 Death