BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 2092855 · Received May 5, 2011

    Report

    Report Number
    1644487-2011-01010
    Event Type
    Malfunction
    Date Received
    May 5, 2011
    Date of Event
    January 1, 2011
    Report Date
    April 5, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL REPORT INADVERTENTLY REPORTED THE SEIZURE FREQUENCY INCORRECTLY. THE SUPPLEMENTAL REPORT #1 INADVERTENTLY REPORTED THE INCORRECT DATE. THE DATE SHOULD HAVE BEEN (B)(4) 2013.

    Additional Manufacturer Narrative · 1

    DEVICE FAILURE IS SUSPECTED.

    Additional Manufacturer Narrative · 1

    THE INITIAL REPORT INDICATED THAT CLINIC NOTES RECEIVED INDICATED THAT THE PATIENT WAS HAVING AN INCREASE IN SEIZURE TO 40-50 SEIZURES PER MONTH HOWEVER THERE WAS NO SEIZURE FREQUENCY LISTED ONLY THAT THE PATIENT WAS HAVING SEIZURES EVER THREE TO FOUR DAYS. FOLLOW-UP WITH THE OFFICE INDICATED THAT THE PATIENT WAS HAVING 20-40 SEIZURES PER MONTH.

    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.

    Description of Event or Problem · 1

    AN IMPLANT CARD LATER REPORTED THAT THE PATIENT HAD GENERATOR AND LEAD REPLACEMENT ON (B)(6) 2015. THE REASON FOR REPLACEMENT WAS DUE TO LEAD DISCONTINUITY. THE EXPLANTED PRODUCTS HAVE NOT BEEN RECEIVED BY THE MANUFACTURER TO DATE. THE RELATIONSHIP OF THE SEIZURES TO BASELINE IS UNKNOWN; HOWEVER, THE PATIENT NOTED SHE WAS NOW HAVING 40-50 SEIZURES PER MONTH.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION AS BEE RECEIVED THAT THE PATIENT STILL HAD NOT HAD SURGERY. THE PATIENT IS DEALING WITH SO PERSONAL ISSUES AND DOES NOT WANT TO HAVE SURGERY AT THIS TIME. EVENTUAL SURGERY IS LIKELY BUT HAS NOT OCCURRED TO DATE. THE PATIENT IS CONTINUING TO HAVE 3-5 SEIZURES PER MONTH PER RECENT CLINIC NOTES.

    Description of Event or Problem · 1

    CLINIC NOTES DATED (B)(6) 2013 WERE RECEIVED ON (B)(6) 2013. THE NOTES INDICATE THAT THE PATIENT HAS A VNS THAT HAS NOT WORKED IN THE LAST 2 YEARS, AND THE BATTERY IS DEAD. THE PATIENT CONTINUED TO HAVE 3-5 SEIZURES PER MONTH AND ARE GTC AND SMALL SEIZURES. THE PATIENT WANTED THE VNS BATTERY CHANGED; HOWEVER, IT WAS ALSO NOTED THAT THE PATIENT WANTED HER VNS REMOVED BECAUSE IT HAD BEEN INACTIVE FOR THE PAST THREE YEARS. SURGERY IS LIKELY BUT HAS NOT TAKEN PLACE.

    Description of Event or Problem · 1

    THE EXPLANTED GENERATOR AND LEAD WERE RECEIVED BY THE MANUFACTURER FOR ANALYSIS. HOWEVER, ANALYSIS HAS NOT BEEN COMPLETED TO DATE.

    Description of Event or Problem · 1

    ANALYSIS WAS COMPLETED ON THE DEVICES. THE ABRADED OPENING FOUND IN THE LEAD ON THE OUTER SILICONE TUBING AND THE CUT ENDS THAT WERE MADE DURING THE EXPLANTED PROCESS, MOST LIKELY PROVIDED THE LEAKAGE PATH FOR THE DRIED REMNANTS OF WHAT APPEARED TO HAVE ONCE BEEN BODY FLUIDS INSIDE THE OUTER SILICONE TUBING. FOR THE OBSERVED INNER TUBING FLUID REMNANTS, THERE WAS NO OBVIOUS PATH FOR FLUID INGRESS OTHER THAN THE CUT ENDS THAT WERE MADE DURING THE EXPLANTED PROCESS. THE CONDITION OF THE RETURNED LEAD PORTIONS IS CONSISTENT WITH CONDITIONS THAT TYPICALLY EXIST FOLLOWING AN EXPLANT PROCEDURE. NO OBVIOUS ANOMALIES WERE NOTED. CONTINUITY CHECKS OF THE RETURNED LEAD PORTIONS WERE PERFORMED, DURING THE VISUAL ANALYSIS, AND NO DISCONTINUITIES WERE IDENTIFIED. NOTE THAT SINCE THE ELECTRODE ARRAY SECTION WAS NOT RETURNED FOR ANALYSIS, AN EVALUATION AND RESULTING COMMENTARY CANNOT BE MADE ON THAT PORTION OF THE LEAD. THE GENERATOR WAS CONFIRMED TO BE AT NEAR END OF SERVICE BATTERY CONDITION. THERE WERE NO ANOMALIES FOUND WITH THE PULSE GENERATOR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S VNS INDICATED HIGH IMPEDANCE WITH A DCDC=7 AT A RECENT OFFICE VISIT. CLINIC NOTES RECEIVED INDICATE THAT THE PATIENT'S SEIZURE FREQUENCY HAS INCREASED RECENTLY TO APPROXIMATELY 40-50 SEIZURES PER MONTH, HOWEVER, THE RELATIONSHIP TO PRE-VNS BASELINE IS UNKNOWN. THE PATIENT HAS NOT FELT STIMULATION FOR APPROXIMATELY 3 MONTHS. THE NOTES ALSO STATED THAT THE VNS GENERATOR RECENTLY "STOPPED WORKING" AND SHOWED "AN ERROR SAYING THAT MOST LIKELY THE BATTERY IS DEAD." A BATTERY LIFE CALCULATION ESTIMATED 2.71 YEARS UNTIL END OF SERVICE. FOLLOW-UP WITH THE PHYSICIAN'S OFFICE FOUND THAT THE PATIENT'S VNS HAS NOT BEEN DISABLED BUT SHE IS PLANNED TO BE DISABLED AT THE NEXT VISIT. CHEST AND NECK X-RAYS ARE ALSO PLANNED FOR THE NEXT VISIT TO CHECK FOR A LEAD FRACTURE. THE PATIENT DID NOT ATTEND HER LAST VISIT WHEN THEY WERE PLANNING TO TAKE X-RAYS AND DISABLE THE VNS AND THE SITE HAS NOT BEEN ABLE TO CONTACT THE PATIENT. NO TRAUMA OR MANIPULATION HAS BEEN REPORTED. SURGERY TO REPLACE THE VNS LEAD AND GENERATOR WILL BE PLANNED FOLLOWING THE NEXT VISIT WITH THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LYJ CYBERONICS, INC. 302-20 1421

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention