BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WIDE-SPACED QUATTRODE LEAD, 110CM LENGTH

    MDR report key: 1790722 · Received August 6, 2010

    Report

    Report Number
    1627487-2010-01601
    Event Type
    Injury
    Date Received
    August 6, 2010
    Date of Event
    July 23, 2009
    Report Date
    July 24, 2009
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    Product Code
    LGW
    PMA / PMN Number
    K072462
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE 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 A PART OF A RETROSPECTIVE REVIEW INITIATED IN 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 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. ANS DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE PT RECEIVED HER SCS SYSTEM ON (B)(6) 2009. IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE OF TWO LEADS IN THE OCCIPITAL AREA (OFF-LABEL), THE FIRST LEAD POKED THROUGH THE PT'S SCALP. THE LEAD WAS DISCARDED. AT THE END OF THE PROCEDURE, THE PHYSICIAN NOTICED THAT ANOTHER ONE OF THE LEADS HAD POKED THROUGH THE SCALP UNDER THE DRAPES. THE PHYSICIAN CUT OPEN THE SCALP, PUSHED THE LEAD IN, AND SUTURED THE SCALP CLOSED. THE PT HAD GREAT STIMULATION AFTER THE PROCEDURE. NO LEADS WERE RETURNED TO ANS FOR EVAL. NO FURTHER INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WIDE-SPACED QUATTRODE LEAD, 110CM LENGTH SPINAL CORD STIMULATION LEAD LGW ADVANCED NEUROMODULATION SYSTEMS 3161 2743948

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention