BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUATTRODE 3/4 LEAD, 60CM LENGTH

    MDR report key: 1834203 · Received September 13, 2010

    Report

    Report Number
    1627487-2010-02041
    Event Type
    Injury
    Date Received
    September 13, 2010
    Date of Event
    January 11, 2008
    Report Date
    January 31, 2008
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    LEAD RETURNED INCOMPLETE WITH LARGE AMOUNT OF DARK COLORATION INSIDE THE LEAD BODY BUT NO VISIBLE SIGNS OF BROKEN WIRES. THIS MDR IS BEING SUBMITTED PAST THE 30 DAY REPORTING REQUIREMENT AS 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 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. ANS DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE PT (B)(6) RECEIVED HER SCS SYSTEM INCLUDING AN IPG, PADDLE LEAD, AND PERCUTANEOUS LEADS ON (B)(6)2007. IT WAS REPORTED THAT THE PT WAS EXPERIENCING INEFFECTIVE STIMULATION AND ABDOMINAL OVERSTIMULATION. THE SYSTEM WAS EXPLANTED ON (B)(6)2008 AND RETURNED TO ANS FOR EVALUATION. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUATTRODE 3/4 LEAD, 60CM LENGTH SPINAL CORD STIMULATION LEAD LGW ADVANCED NEUROMODULATION SYSTEMS 3146

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention