BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE PERCUTANEOUS LEAD

    MDR report key: 1870577 · Received September 29, 2010

    Report

    Report Number
    1627487-2010-01738
    Event Type
    Injury
    Date Received
    September 29, 2010
    Date of Event
    August 2, 2007
    Report Date
    August 3, 2007
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION METHOD: 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. (B)(4). 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

    DEVICE 3 OF 3. REFERENCE MANUFACTURER REPORT: 1627487-2010-01736 AND 1627487-2010-01737. THE PATIENT RECEIVED HER SCS SYSTEM CONSISTING OF TWO PERCUTANEOUS LEADS AND AN IPG ON (B)(6) 2007. IN (B)(6) 2007, THE PATIENT UNDERWENT A MAGNETIC RESONANCE IMAGING (MRI) PROCEDURE. AS INDICATED IN THE DEVICE LABELLING, MRI PROCEDURES ARE CONTRAINDICATED FOR PATIENTS WITH AN IMPLANTED SCS SYSTEM. AFTER THE MRI WAS COMPLETED, THE PATIENT REPORTED FEELING OVERSTIMULATION FROM THE SCS SYSTEM WHEN USING HER PATIENT PROGRAMMER OR DEVICE CHARGER. AN X-RAY OF THE PATIENT'S SYSTEM WAS TAKEN AND REVEALED THAT ONE LEAD HAD MOVED FROM A POSTERIOR POSITION TO AN ANTERIOR POSITION. THE PATIENT'S SCS SYSTEM WAS EXPLANTED ON (B)(6) 2007. ACCORDING TO THE MANUFACTURER'S DEVICE REGISTRATION SYSTEM, THE PATIENT WAS NOT REIMPLANTED. THE DEVICES WERE NOT RETURNED TO ANS FOR EVALUATION. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE PERCUTANEOUS LEAD PERCUTANEOUS LEAD LGW ADVANCED NEUROMODULATION SYSTEMS 3186 69989

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention