BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 3203111 · Received July 2, 2013

    Report

    Report Number
    1644487-2013-02014
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 6, 2013
    Report Date
    June 12, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ONLY A PORTION OF THE LEAD WAS RETURNED FOR ANALYSIS WHICH DID NOT REVEAL ANY ANOMALIES. DEVICE FAILURE IS SUSPECTED IN THE LEAD PORTION NOT RETURNED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF DIAGNOSTIC HISTORY PERFORMED. DESCRIBE EVENT OR PROBLEM, CORRECTED DATA: REVIEW OF THE CLINIC NOTES FROM THE SURGEON DATED (B)(6) 2013 REVEALED THAT THE PATIENT'S RECENT INCREASE IN SEIZURES WAS 4-5 PER DAY, NOT 30 PER DAY AS WAS PREVIOUSLY REPORTED ON THE INITIAL MDR. THE INFORMATION HAS BEEN CORRECTED ON THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN INCREASED SEIZURES. IT WAS REPORTED THAT WHEN THE VNS WAS IMPLANTED THE PATIENT¿S SEIZURES WENT FROM 50 SEIZURES PER DAY TO 0 PER DAY. HER SEIZURES WERE REPORTEDLY INCREASED RECENTLY TO 30 PER DAY. THE PATIENT¿S SURGEON STATES THAT THE VNS GENERATOR IS AT DCDC 0 WHICH MIGHT SUGGEST THAT THE VNS LEAD IS NOT OPERATIONAL WHICH MIGHT BE THE CAUSE OF THE INCREASED SEIZURES. ATTEMPTS FOR ADDITIONAL INFORMATION REGARDING THE INCREASED SEIZURES AND LOW IMPEDANCE HAVE BEEN MADE TO THE PATIENT¿S TREATING PHYSICIAN, BUT HAVE BEEN UNSUCCESSFUL TO DATE. THE DEVICE HISTORY REPORT WAS REVIEWED BUT NO UNRESOLVED NON CONFORMANCES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A CONSULTATION FOR A GENERATOR REPLACEMENT ON (B)(6) 2013. FULL REVISION WAS PERFORMED ON (B)(6) 2013 DUE TO THE DCDC CODE OF 0. THE DEVICE WAS RETURNED ON (B)(6) 2013 AND IS PENDING PRODUCT ANALYSIS.

    Description of Event or Problem · 1

    THE CLINIC NOTES FROM THE NEUROLOGIST DATED (B)(6) 2012 INDICATED THE PATIENT WAS HAVING ABOUT 4 TO 5 SEIZURES PER DAY AT THAT TIME. THE OUTPUT CURRENT WAS INCREASED AT THAT VISIT. NOTES FROM THE PATIENT¿S PREVIOUS OFFICE VISIT ON (B)(6) 2012 VISIT WERE ALSO REVIEWED. VNS WAS NOT PROGRAMMED AT THAT VISIT, AND IT DOES NOT APPEAR ANY MEDICATION CHANGES WERE MADE.

    Description of Event or Problem · 1

    ANALYSIS OF THE LEAD WAS COMPLETED ON (B)(4) 2013. THE REPORTED LEAD FRACTURE AND LOW IMPEDANCE WAS NOT VERIFIED WITHIN THE RETURNED LEAD PORTION. THE OUTER TUBING IS ABRADED OPEN. NOTE THAT SINCE THE ELECTRODE ARRAY PORTION WAS NOT RETURNED FOR ANALYSIS, AN EVALUATION AND RESULTING COMMENTARY CANNOT BE MADE ON THAT PORTION OF THE LEAD. OTHER THAN TYPICAL WEAR AND EXPLANT RELATED OBSERVATIONS, NO ANOMALIES WERE IDENTIFIED IN THE RETURNED LEAD PORTION. ANALYSIS OF THE EXPLANTED GENERATOR WAS ALSO COMPLETED. A COMPREHENSIVE AUTOMATED ELECTRICAL EVALUATION SHOWED THAT THE PULSE GENERATOR PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. THERE WERE NO PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITIONS FOUND WITH THE PULSE GENERATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302699 LEAD MODEL 302 LEAD LYJ CYBERONICS, INC. 302-20 1150

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR