BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 2880597 · Received December 19, 2012

    Report

    Report Number
    1644487-2012-03374
    Event Type
    Malfunction
    Date Received
    December 19, 2012
    Date of Event
    September 3, 2012
    Report Date
    November 21, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    OPERATIVE NOTES WERE RECEIVED FROM THE DATE OF SURGERY. DATE OF SURGERY WAS NOTES TO BE (B)(6) 2012. THERE WAS NO EVIDENCE OF A SEROMA OR OTHER INFECTIOUS PROCESS AND THE LEAD INSERTION APPEARED NORMAL. APPROXIMATELY 3-4 CM FORM THE INSERTION INTO THE GENERATOR THERE WAS SEEN TO BE A SMALL TEAR IN THE INSULATION WITH FLUID INSIDE THE TUBING WHICH THE SURGEON FELT WAS THE REASON FOR THE HIGH IMPEDANCE. A NEW GENERATOR WAS CONNECTED THE LEAD AND THE HIGH IMPEDANCE WAS STILL PRESENT. THE MASS WAS DETERMINED TO BE A SUTURE GRANULOMA OR PERHAPS AN INFLAMMATORY LYMPH NODE FROM THE PATIENT¿S INITIAL IMPLANT IN 2005. THERE WAS NO INDICATION OF AN INFECTION. THE MASS WAS DETERMINED TO BE A FIBROUS CAPSULE OF FIBROUS CONNECTIVE TISSUE WITH CYSTIC AREA.

    Description of Event or Problem · 1

    ON (B)(6) 2012 THE PHYSICIAN REPORTED THAT THE PATIENT WAS SEEN IN CLINIC THAT DAY AND WAS FOUND TO HAVE A LEAD IMPEDANCE OF GREATER THAN 10,000 OHMS. THE PATIENT'S VNS WAS TURNED OFF AND X-RAYS OF THE NECK AND CHEST WERE ORDERED. IT IS UNKNOWN IF THE X-RAYS WILL BE SENT TO THE COMPANY FOR REVIEW. THERE WAS NO EVIDENCE OF PATIENT MANIPULATION OR TRAUMA THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE HIGH IMPEDANCE. A REVIEW OF CLINIC NOTES DATED (B)(6) 2012 NOTED THAT THE PATIENT HAD BEEN ALMOST ONE YEAR FREE WITHOUT SEIZURES, BUT HAD THREE SEIZURES ON (B)(6) 2012. THE PATIENT WAS STATED TO BE UNRESPONSIVE TO MAGNET SWIPES. THE PATIENT UNDERWENT A LEAD REPLACEMENT SURGERY ON (B)(6) 2012. ADDITIONAL INFORMATION WAS RECEIVED FROM THE SURGEON WHO STATED THAT WHEN EXPLANTING THE LEAD HE FOUND WHAT APPEARED TO BE A FRACTURE IN THE AREA OF THE LEAD RIGHT ABOVE THE GENERATOR SITE. WHEN REMOVING THE HELICES OFF THE NERVE, THE SURGEON NOTED A GRANULOMA THAT APPEARED TO HAVE STERILE PUSS IN IT LIKELY FROM THE ORIGINAL IMPLANT. THE SURGEON STATED THAT HE DOES NOT FEEL THE GRANULOMA IS AN INFECTION AS THE PATIENT NEVER HAD SYMPTOMS AND THE GRAM STAIN WAS NEGATIVE. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 1

    PRODUCT ANALYSIS OF THE RETURNED GENERATOR FOUND NO ANOMALIES. THE REPORTED DEMIPULSE EOS WAS NOT DUPLICATED IN THE PRODUCT ANALYSIS LAB. RESULTS OF DIAGNOSTIC TESTING INDICATED THE DEVICE OPERATED AND COMMUNICATED PROPERLY. ELECTRICAL TEST RESULTS SHOWED THAT THE PULSE GENERATOR PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. THERE WERE NO ADVERSE FUNCTIONAL, MECHANICAL, OR VISUAL ISSUES IDENTIFIED WITH THE RETURNED GENERATOR. PRODUCT ANALYSIS ON THE RETURNED PORTION OF THE EXPLANTED LEAD FOUND A LEAD BREAK AND CORROSION (ELECTRO-ETCHING/PITTING). IT WAS NOTED THAT A LARGE PORTION OF THE LEAD ASSEMBLY (BODY) INCLUDING THE ELECTRODES WAS NOT RETURNED FOR ANALYSIS; THEREFORE A COMPLETE EVALUATION COULD NOT BE PERFORMED ON THE ENTIRE LEAD PRODUCT. DURING THE VISUAL ANALYSIS THE CONNECTOR PIN QUADFILAR COIL APPEARED TO BE BROKEN APPROXIMATELY 236MM FROM THE END OF THE CONNECTOR BOOT. SCANNING ELECTRON MICROSCOPY WAS PERFORMED AND IDENTIFIED THE AREA AS BEING THIN WHICH PREVENTED IDENTIFICATION OF THE COIL FRACTURE TYPE WITH EVIDENCE OF ELECTRO-ETCHING AND PITTING ON THE SURFACE. IT IS BELIEVED THAT STIMULATION WAS PRESENT FOR A CERTAIN PERIOD OF TIME AS EVIDENCED BY THE PRESENCE OF METAL PITTING. LOW MAGNIFICATION SEM ANALYSIS OF THE QUADFILAR COIL SHOWS CHARACTERISTICS TYPICAL OF A LEAD DISCONTINUITY WHICH MAY INCLUDE: MATERIAL FRACTURE, ROUGH OR PITTED SURFACE, THINNED MATERIAL THICKNESS, ELECTRO-ETCHING OR MATERIAL DISSOLUTION. WITH THE EXCEPTION OF THE OBSERVED DISCONTINUITY, THE CONDITION OF THE RETURNED LEAD PORTION IS CONSISTENT WITH CONDITIONS THAT TYPICALLY EXIST FOLLOWING AN EXPLANT PROCEDURE. THE SETSCREW MARKS FOUND ON THE LEAD CONNECTOR PIN PROVIDE EVIDENCE THAT, AT ONE POINT IN TIME, A GOOD MECHANICAL AND ELECTRICAL CONNECTION WAS PRESENT. CONTINUITY CHECKS OF THE RETURNED LEAD PORTION WERE PERFORMED, DURING THE VISUAL ANALYSIS, AND NO OTHER DISCONTINUITIES WERE IDENTIFIED. BASED ON THE FINDINGS IN THE PRODUCT ANALYSIS LAB, THERE IS EVIDENCE TO SUGGEST A DISCONTINUITY IN THE RETURNED PORTION OF THE DEVICE WHICH MAY HAVE CONTRIBUTED TO THE STATED ALLEGATIONS A LEAD BREAK. SINCE A LARGE PORTION OF THE LEAD ASSEMBLY (BODY) INCLUDING THE ELECTRODE ARRAY SECTION WAS NOT RETURNED FOR ANALYSIS, AN EVALUATION AND RESULTING COMMENTARY CANNOT BE MADE ON THAT PORTION OF THE LEAD. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 1

    UPON A SECOND REVIEW OF THE CLINIC NOTES, IT DOES NOT APPEAR THAT THERE IS AN ALLEGATION OF THE MAGNET NOT ABORTING SEIZURES. THE NOTES INDICATED "UNRESPONSIVE 1 MINUTE - MAGNET SWIPE." IN ADDITION, THE REPORTED OF THE INCREASE IN SEIZURES IS NOT BELIEVED TO BE RELATED TO VNS. THE NOTES INDICATED THAT THE INCREASE IS RELATED TO THE PATIENT'S BIRTH CONTROL PILLS.

    Description of Event or Problem · 1

    AN INVESTIGATION WAS INITIATED IN RESPONSE TO A TREND IN LEAD FAILURE EVENTS NOTED WITH PATIENT IMPLANTED WITH THE ORIGINAL MODEL 105 GENERATOR DESIGN ((B)(4)). THE INVESTIGATION DETERMINED THAT IN THE EVENT THAT THE LEAD BECOMES COMPROMISED THROUGH WEAR OR TRAUMA (E.G. AN ABRADED OPENING IN THE LEAD¿S SILICONE TUBING), A CHARGE IMBALANCE MAY FORM AT THIS LOCATION AS A RESULT OF THE ALTERNATE CURRENT PATHWAY ASSOCIATED WITH THE ORIGINAL MODEL 105 GENERATOR DESIGN ((B)(4)). AS A RESULT OF THIS CHARGE IMBALANCE AND THE LOW PITTING POTENTIAL OF MP35N QUADFILAR COIL, COIL CORROSION CAN OCCUR RESULTING IN A LEAD DISCONTINUITY. CORRECTIVE ACTION WAS TAKEN BY THE MANUFACTURER AS A RESULT OF THIS INVESTIGATION. THE GENERATOR THAT THE PATIENT WAS IMPLANTED WITH WHEN THE LEAD BREAK OCCURRED WAS MANUFACTURED PRIOR TO THE CORRECTIVE ACTION.

    Description of Event or Problem · 1

    CLINIC NOTES DATED (B)(6) 2013 WERE RECEIVED IN RESPONSE TO ATTEMPTS FOR ADDITIONAL INFORMATION; HOWEVER, THESE NOTES DID NOT HAVE ANY INFORMATION RELEVANT TO THE REPORTED EVENTS, EXCEPT FOR THE PATIENT'S PROGRAMMING AND DIAGNOSTIC HISTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LEAD LYJ CYBERONICS, INC. 302-20 1008

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Required Intervention