BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 2830719 · Received November 13, 2012

    Report

    Report Number
    1644487-2012-02986
    Event Type
    Malfunction
    Date Received
    November 13, 2012
    Date of Event
    October 15, 2012
    Report Date
    October 15, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE FAILURE OCCURRED BUT DID NOT CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH.

    Additional Manufacturer Narrative · 1

    DEVICE FAILURE IS SUSPECTED BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH.

    Description of Event or Problem · 1

    ON (B)(6) 2012, IT WAS REPORTED THAT THIS VNS PATIENT UNDERWENT GENERATOR REVISION. THE GENERATOR WAS EXPLANTED AND A NEW GENERATOR WAS IMPLANTED; HOWEVER, HIGH IMPEDANCE WAS SEEN. GENERATOR DIAGNOSTICS ON BOTH THE NEW AND OLD GENERATOR WITH THE TEST RESISTOR WERE PERFORMED WITH NORMAL RESULTS. ATTEMPTS TO RE-INSERT THE PIN WERE THREE TIMES WITH THE NEW GENERATOR. DIAGNOSTICS WERE NOT RUN ON THE OLD GENERATOR CONNECTED TO THE LEAD. X-RAYS WERE TAKEN IN THE OPERATING ROOM AND IT WAS VERIFIED THAT SOMETHING WAS WRONG WITH THE LEAD; HOWEVER, THE X-RAYS IMAGES WERE NOT SAVED AND WOULD NOT BE PROVIDED FOR REVIEW. THE NEW GENERATOR WAS PLACED, THE DEVICE WAS LEFT PROGRAMMED OFF, AND THE LEAD WAS NOT REPLACED AT THE TIME OF SURGERY. SURGERY IS LIKELY BUT HAS NOT TAKEN PLACE.

    Description of Event or Problem · 1

    PRODUCT ANALYSIS WAS APPROVED ON (B)(6) 2013. A BREAK WAS IDENTIFIED IN THE POSITIVE COIL. SCANNING ELECTRON MICROSCOPY IMAGES OF THE POSITIVE COIL SHOW THAT PITTING OR ELECTRO-ETCHING CONDITIONS HAVE OCCURRED AT THE BREAK LOCATION. IN ADDITION ABRASIONS IN THE INNER AND OUTER TUBING WERE FOUND. 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 THE ABOVE MENTIONED OBSERVATIONS AND TYPICAL WEAR AND EXPLANT RELATED OBSERVATIONS, NO OTHER ANOMALIES WERE IDENTIFIED IN THE RETURNED LEAD PORTION.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THIS VNS PATIENT UNDERWENT LEAD REVISION. PRE-IMPLANT DIAGNOSTICS INDICATED HIGH IMPEDANCE. THE PATIENT'S GENERATOR WAS LEFT AT THE SETTINGS HE CAME IN TO THE OPERATING ROOM WITH. (THESE SETTINGS ARE INDICATIVE OF A FAULTED SYSTEM DIAGNOSTIC TEST. THIS EVENT IS CAPTURED IN MFR REPORT # 1644487-2013-00002.) POST-IMPLANT DIAGNOSTICS SHOWED PROPER DEVICE FUNCTION. ACCORDING TO THE DOCTORS, THE TOP TWO ELECTRODES OF THE OLD LEAD WERE OFF THE NERVE. THE LEAD WAS RECEIVED ON (B)(4) 2012 AND IS CURRENTLY UNDERGOING PRODUCT ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LEAD LYJ CYBERONICS, INC. 302-20 200631

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR