BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE PERCUTANEOUS LEAD

    MDR report key: 1834136 · Received September 13, 2010

    Report

    Report Number
    1627487-2010-01777
    Event Type
    Injury
    Date Received
    September 13, 2010
    Date of Event
    May 12, 2008
    Report Date
    May 13, 2008
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: 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 DAYS 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 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, WHICH INCLUDED AN IPG AND PERCUTANEOUS LEAD, ON (B)(6)2008. IT WAS REPORTED, THE PATIENT WAS FEELING OVERSTIMULATION SENSATIONS. AN EXAMINATION OF THE PATIENT'S SCS SYSTEM FOUND THE LEAD HAD MIGRATED. IN ORDER TO REGAIN THE PROPER STIMULATION PLACEMENT, THE PHYSICIAN ADDED A SECOND LEAD TO THE PATIENT'S SYSTEM. THE PRODUCT WAS NOT RETURNED TO THE MANUFACTURER FOR ANALYSIS. FOLLOW UP ON THE PATIENT FOUND THAT THE PATIENT CONTINUED TO EXPERIENCE OVERSTIMULATION SENSATIONS, BUT ELECTED NOT TO HAVE ANY ADDITION SURGERIES OR DEVICE REVISIONS. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE PERCUTANEOUS LEAD SPINAL CORD STIMULATION LEAD LGW ADVANCED NEUROMODULATION SYSTEMS 3186 114345

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention