BEUDAMED
    FDA Adverse Event Other Summary report: N

    AURAGEN STRIP 4 CTS

    MDR report key: 2426238 · Received January 13, 2012

    Report

    Report Number
    9612007-2012-00002
    Event Type
    Other
    Date Received
    January 13, 2012
    Date of Event
    December 19, 2011
    Report Date
    January 13, 2012
    Manufacturer
    INTEGRA NEUROSCIENCES IMPLANTS S.A.
    Product Code
    GYC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT EXPECTED TO BE RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DRAWING/DIAGRAM OF THE LEADS ON THE 4 CONTACT STRIPS IN THE PRODUCT INSERT ONLY HIGHLIGHTS THE FIRST FOUR ACTIVE CONTACTS ON THE TAIL OF THE STRIP AND DOES NOT IDENTIFY THE NEXT 4 GOLD LOCKING STRIPS. THE CUSTOMER STATED THAT THE DRAWING IN THE INSERT DOES NOT ACCURATELY PORTRAY THE ENCLOSED PRODUCT AND IS THEREFORE MISLEADING AND MAKES IT MORE DIFFICULT AND CONFUSING WHEN IDENTIFYING THE LEADS ONCE THEY HAVE BEEN CUT OFF OF THE STRIP FOR REMOVAL. ADDITIONAL INFORMATION WAS REQUESTED AND ON JANUARY 4, 2012, THE FOLLOWING INFORMATION WAS RECEIVED FROM THE CUSTOMER, THE AURAGEN STRIP 4 CTS ELECTRODES WERE INITIALLY "LEFT BEHIND" IN A SURGICAL PROCEDURE ONE WEEK EARLIER ON (B)(6) 2011. THE AU1X4P ARE "LEFT BEHIND" PURPOSELY AND THEN LATER REMOVED. ON (B)(6) 2011, THE PT UNDERWENT A CRANIOTOMY FOR THE REMOVAL OF EPILEPTIC FOCI AND THE AURAGEN STRIP. THE CUSTOMER STATED THAT THE DIAGRAM SERVES AS A POINT OF REFERENCE FOR THE SURGICAL TEAM WHEN THE MEDICAL DEVICES ARE REMOVED. WHEN THEY ARE REMOVED, THE ELECTRODE MUST BE ACCOUNTED FOR IN ITS ENTIRETY. THE PRODUCT LITERATURE (DIAGRAM OF THE ELECTRODE'S DISTAL TAIL END) IS NOT ACCURATE. THERE WAS NO ADVERSE PT OUTCOME WITH THIS COMPLAINT. THERE WAS NO DELAY IN SURGERY. THE PRODUCT WAS REMOVED IN IT'S ENTIRETY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AURAGEN STRIP 4 CTS AURAGEN STRIP ELECTRODE GYC INTEGRA NEUROSCIENCES IMPLANTS S.A.

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR