Model Number 101 Event Date 03/03/2008 Event Type Injury Patient Outcome Hospitalization; Required Intervention Event Description Initial reporter called to ask if manufacturer had any info on vns pt's experiencing asystole caused by swiping their magnet or stimulation. It was additionally reported "a pt had a seizure and the nurse swiped with a magnet. Afterwards the pt went into asystole, which lasted several seconds. The pt was in the hospital due to seizures and connected to a monitor so they were able to see it. " the pt's seizure rate was above their pre vns seizure rate and was a change for the pt. No further info has been attained from the site after good faith attempts have been made. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1022608 Model Number 102 Event Date 09/07/2007 Event Type Malfunction Patient Outcome Life Threatening; Hospitalization Required Intervention Other Event Description The reporter indicated the pt was admitted to cardiac care unit for monitoring. The pt experienced an asystole and bradycardia, approx five or six mos ago. The pt was seen for video monitoring for his seizures. During the monitoring, the reporter noted that "the pt would go into "true persistent asystole with no pulse. " in addition, the pt had an asystole only during a magnet swipe which was set for 60 seconds on. The reporter stated the pt's magnet output current was set to 3. 5 ma. The reporter indicated the normal stimulation was set to 1. 5 ma. The reporter stated "the pt was having a seizure and they swiped the device initiating a magnet mode stimulation. " the reporter noted the asystole was longer, than when they swiped the pt without a seizure. The reporter stated "the asystole and bradycardia are directly related to vns stimulation. " during the pt's admission in the ccu, the reporter lowered the magnet output current to see how the pt would respond to the new settings. The reporter stated the pt was set to 2. 25ma. Thus, the pt no longer had asystole, but bradycardia. The reporter states "this setting does not help the pt's seizures to abort, but the cardiologist was fine with the bradycardia. " the reporter stated "the pt is fine now, just not getting as good of seizure control with the new setting. " good faith attempts to obtain additional info are in progress and awaiting results. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1009251 Model Number 102 Event Date 01/01/2006 Event Type Injury Patient Outcome Life Threatening; Hospitalization Required Intervention Event Description Vns pt was hospitalized with asystole. While hospitalized, the pt's device was programmed to off, after which his condition stabilized. While attempting to reinitiate device stimulation, the pt exhibited asystole again. Treating physician programmed the device back to off and does not plan to reinitiate stimulation. The pt had reportedly been experiencing good seizure control with the vns therapy and his device had been programmed to 3. 0ma normal mode output current "for quite a while". It was reported that since the incident, the pt is unable to tolerate even lower levels of stimulation, due to the cardiac condition. The pt is non-verbal and cannot communicate whether device stimulation feels abnormal. The pt does not have any pre-existing conditions that may have precipitated the reported event and there had been no recent changes to the pt's medication regimen. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=675911 Model Number 101 Event Date 01/10/2006 Event Type Injury Patient Outcome Life Threatening; Hospitalization Required Intervention Manufacturer Narrative Ncp system labeling lists heart rate/rhythm changes as a potential adverse event possibly associated with surgery or stimulation. Treating physician indicates that the reported events appear to be related to device stimulation ("vagally-induced heart block and sinus bradycardia") but does not know why the pt began to experience these events after more than two years of successful vns therapy. Event Description Reporter indicated that pt suddenly began to experience serious drop attacks unrelated to his epilepsy. The pt had been implanted for approx 29 months when the drop attacks began and had experienced good efficacy with the vns therapy regarding his seizure control. There had been no changes to either programmed parameters or medication regimen for approx one year. The pt was hospitalized, during which time it was discovered that he was experiencing episodes of bradycardia leading to asystole during device stimulation cycles. The pt also experienced several episodes of syncope during this time. No heart condition has been reported that the pt's device was functioning normally, although specific device diagnostic test results were not provided by physician. Stimulation has been discontinued and explant of the ncp system is planned. The episodes of syncope have reportedly resolved since the device was programmed to off; however the pt's seizures have somewhat worsened in the absence of the vns therapy (to approx 1 seizure per wk). Treating physician indicates that the reported events appear to be related to device stimulation ("vagally-induced heart block and sinus bradycardia") but does not know why the pt began to experience these events after more than two yrs of successful vns therapy. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=689307 Model Number 101 Event Date 05/01/2006 Event Type Injury Patient Outcome Life Threatening; Hospitalization Required Intervention Event Description Reporter indicated that pt began to experience episodes of syncope and asystole approximately six years post vns implant. The pt reported feeling the need to cough, after which he reportedly lost consciousness. Approximately two months after, the onset of symptoms, the pt was hospitalized for eval of the syncope episodes, at which time and ekg revealed episodes of asystole that coincided with device stimulation cycles; however, not every stimulation cycle would produce this event. The vns therapy system was then programmed to off, after which a repeat ekg was normal. The pt did not experience any further episodes of syncope or asystole in the absence of the vns therapy. Eval by cardiologist did not reveal any abnormalities with the pt's heart. The device remains programmed to off. Both the cardiologist and the neurologist believe that the reported events were caused by the stimulation of the vagus nerve. There had been no recent changes to programmed device settings; however, inderal had recently been added to the pt's medication regimen for treatment of mild hypertension. Manufacturer Narrative Results - (b) (4) system labeling lists heart rate/rhythm changes as a potential adverse event possibly associated with surgery or stimulation. Conclusions - treating physician indicates that the reported events appear to be related to device stimulation; however, the physician does not know why the pt began to experience these events after more than six years of successful vns therapy. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1629932 Model Number 101 Event Date 12/04/2008 Event Type Injury Patient Outcome Life Threatening; Required Intervention Event Description It was reported in a scientific article that a vns patient, who had been receiving vns therapy for nine years without complaint, was admitted to the hospital for the control of an episode status epilepticus, an event not uncommon for the patient, for which medication was administered. The patient experienced an increase in seizures during the hospital stay and eeg monitoring revealed the occurrence of periodic cardiac changes with bradyarrhythmia and often severe asystolia due to atrium ventricular block, which coincided with stimulation. The patient was admitted to the cardiac intensive care unit and underwent holter monitorization, because the periodicity of the bradyarrhythmias was the same as that of the ncp stimulation (around 30 s every 5. 5 min), the ncp was stopped. Once the device was disabled, the reported arrhythmia event resolved. The reporter states that though there appears to be a clear relationship to vns therapy, other contributing factors were believed to be present. These factors include the addition of levetiracetam, which had a notable arrhythmic effect on the patient. The author also suggests that the patient's status episode may have predisposed the patient to the vns-related cardiac arrhythmia. Manufacturer Narrative Article citation: iriarte, jorge, elena urrestarazu, manuel alegre, alfonso macias, asier gomez, paola amaro, julio artieda, and cesar viteri. "late-onset periodic asystolia during vagus nerve stimulation. " epilepsia 49 (2008): 1-5. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1276878
