BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 2983415 · Received February 28, 2013

    Report

    Report Number
    1644487-2013-00549
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    September 14, 2010
    Report Date
    January 31, 2013
    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
    NH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    ADVERSE EVENT AND/OR PRODUCT PROBLEM; CORRECTED DATA: THE PREVIOUSLY SUBMITTED MDR INADVERTENTLY STATED THAT THE EVENT WAS BOTH AN ADVERSE EVENT AND PRODUCT PROBLEM. THE EVENT IS CONSIDERED ONLY A PRODUCT PROBLEM. THIS MDR IS BEING SUBMITTED TO CORRECT THIS DATA. ADVERSE EVENT AND/OR PRODUCT PROBLEM; CORRECTED DATA: THE PREVIOUSLY SUBMITTED MDR INADVERTENTLY STATED THAT THE EVENT WAS BOTH AN ADVERSE EVENT AND PRODUCT PROBLEM. THE EVENT IS CONSIDERED ONLY A PRODUCT PROBLEM. THIS MDR IS BEING SUBMITTED TO CORRECT THIS DATA.

    Additional Manufacturer Narrative · 1

    ADVERSE EVENT AND/OR PRODUCT PROBLEM; CORRECTED DATA: ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE EVENT IS BOTH AN ADVERSE EVENT AND PRODUCT PROBLEM.

    Description of Event or Problem · 1

    WHILE REVIEWING INTERNAL PROGRAMMING HISTORY ON THE PATIENT'S VNS GENERATOR, HIGH IMPEDANCE WAS NOTED ON THEIR NORMAL MODE DIAGNOSTIC TEST WITH NO CORRESPONDING SYSTEM DIAGNOSTIC TEST. THEIR TREATING PHYSICIAN REPORTED THAT HE WAS TRYING TO CONTACT THE PATIENT IN REGARDS TO THEIR HIGH IMPEDANCE BUT HAD BEEN UNSUCCESSFUL. HE DID NOT THINK THAT THEIR VNS THERAPY WAS EFFECTIVE THEREFORE MAY NOT PURSUE FURTHER. NO FURTHER INFORMATION HAS BEEN RECEIVED IN REGARDS TO THEIR REPORTED HIGH IMPEDANCE EVENT.

    Description of Event or Problem · 1

    CLINIC NOTES WERE RECEIVED FOR PATIENT. NOTES INDICATE THAT THE PATIENT ASKED THE DEVICE TO BE TURNED OFF DUE TO HIS BELIEF THAT THE DEVICE PRESENTED HIM FROM SLEEPING. THE DEVICE WAS TURNED A YEAR LATER FROM IMPLANT PER NOTES POSSIBLY DUE TO SLEEP DISTURBANCE AND LACK OF EFFICACY. PATIENT ALSO EXPERIENCED EPISODES OF "BLACKOUTS" STARTING SHORTLY AFTER VNS BEING TURNED OFF. TURNING ON VNS AGAIN WAS DISCUSSED WITH THE PHYSICIAN. THERE IS NO EVIDENCE OF EVEN TEMPORARY DEVICE DISABLEMENT PER PROGRAMMING HISTORY. NO OTHER RELEVANT INFORMATION WAS RECEIVED.

    Description of Event or Problem · 1

    PATIENT UNDERWENT GENERATOR REPLACEMENT DUE TO BATTERY DEPLETION AND UNABLE TO INTERROGATE ON (B)(6) 2016. THE LEAD WAS NOT REPLACED AND THE HIGH IMPEDANCE WAS OBSERVED WITH THE NEW GENERATOR WITH IMPEDANCE OF > 10000 OHMS. THE EXPLANTED GENERATOR WAS RECEIVED ON 08/03/2016. ANALYSIS IS UNDERWAY BUT HAS NOT BEEN COMPLETED TO DATE. PATIENT UNDERWENT LEAD REVISION SURGERY ON (B)(6) 2016. THE EXPLANTED LEAD WAS CUT IN PIECES AND WILL NOT BE RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    ANALYSIS ON THE GENERATOR WAS COMPLETED. THE ALLEGED ¿EOS¿, ¿FAILURE TO PROGRAM¿ AND ¿NO STIMULATION¿ EVENTS WERE DETERMINED TO BE THE RESULT OF NORMAL BATTERY DEPLETION. BASED ON THE ELECTRICAL TEST RESULTS, THE DEVICE EXHIBITED CURRENT CONSUMPTION RATES THAT ARE WITHIN SPECIFICATION, THEREBY DEMONSTRATING NORMAL BATTERY DEPLETION TO AN END-OF-SERVICE CONDITION. THE ELECTRICAL PERFORMANCE OF THE GENERATOR, AS MEASURED IN THE PA LAB, WILL BE USED TO CONCLUDE THAT NO ANOMALIES EXIST AND THE EOS CONDITION IS AN EXPECTED EVENT. THE MODULE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS . THERE WERE NO PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITIONS FOUND WITH THE PULSE GENERATOR.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE VNS PATIENT¿S DEVICE WAS TESTED AND SYSTEM DIAGNOSTIC RESULTS SHOWED HIGH IMPEDANCE AND A LOW BATTERY CONDITION. THE PATIENT¿S DEVICE WAS DISABLED BUT THE PATIENT SUBSEQUENTLY BEGAN EXPERIENCING AN INCREASE IN SEIZURES. THE PATIENT DECLINED TO HAVE HIS DEVICE REPLACED AND NO KNOWN SURGICAL INTERVENTIONS HAVE OCCURRED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86058 LEAD MODEL 302 LEAD LYJ CYBERONICS, INC. 302-20 929

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other