BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE TRIPOLE 16C PADDLE LEAD

    MDR report key: 1790729 · Received August 6, 2010

    Report

    Report Number
    1627487-2010-01547
    Event Type
    Injury
    Date Received
    August 6, 2010
    Date of Event
    August 11, 2008
    Report Date
    September 18, 2008
    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

    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 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 CONSISTING OF A PADDLE LEAD ON (B)(6) 2008. A DURAL SEPARATOR WAS USED IN THE PROCEDURE. IT WAS REPORTED THAT THE PATIENT EXPERIENCED MAJOR ABDOMINAL CRAMPING IN THE RECOVERY ROOM. THIS CRAMPING PERSISTED FOR APPROXIMATELY 1-2 WEEKS BUT WAS COMPLETELY RESOLVED IN 1-2 MONTHS. THE LEAD REMAINED IMPLANTED AND THE PATIENT HAD GOOD STIMULATION COVERAGE. NO FURTHER INFORMATION IS AVAILABLE. FOLLOW-UP ON THE PATIENT FOUND NO FURTHER ISSUES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE TRIPOLE 16C PADDLE LEAD SPINAL CORD STIMULATION LEAD LGW ADVANCED NEUROMODULATION SYSTEMS 3214 114711

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention