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Author Topic: Cyberonics Says SUDEP  (Read 2500 times)
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dennis100
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« on: February 24, 2019, 03:09:07 AM »

Model Number 102
Event Date 07/15/2005
Event Type  Death   
Manufacturer Narrative

Event Description
It was reported that the patient passed away on (b)(6) 2005. The patient¿s last known neurologist has no record of the patient in their system; therefore, no further information can be received from the physician. Per the department of vital records in the state the patient passed away in, the manufacturer is not eligible to obtain a copy of the patient¿s death certificate. A sudep evaluation was performed by the manufacturer which determined the patient¿s death to be possible sudep.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4398028
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dennis100
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« Reply #1 on: February 24, 2019, 03:09:53 AM »

Model Number 102
Event Type  Death   
Event Description
This death event has been reviewed and with the available information has been determined to be possible sudep by manufacturer nurse. The only known factors are that the patient had epilepsy and died. As such, sudep cannot be ruled out as a possible cause of death. Attempts for further information have been unsuccessful to date and the physician has no further information on the event.
 
Manufacturer Narrative

Event Description
It was reported that the patient had passed away. No other information is known at this time. Attempts for further information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2378305
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dennis100
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« Reply #2 on: February 24, 2019, 03:10:25 AM »

Model Number 102
Event Date 06/09/2005
Event Type  Death   
Event Description
It was reported that the pt was deceased. No cause of death or other info was given. Attempts for further info have been unsuccessful to date.
 
Event Description
This death event has been reviewed by a manufacturer nurse and with the available information has been determined to be possible sudep. The patient had epilepsy and died, but no other information is known. As such, sudep cannot be ruled out as a possible cause of death. Attempts for further information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2405539
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dennis100
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« Reply #3 on: February 24, 2019, 03:11:05 AM »

Model Number 101
Event Date 06/10/2010
Event Type  Death   
Event Description
It was reported via a call from the coroner's office that they were attempting to confirm the identity of a patient who was implanted with a vns device. The patient's name and device information was confirmed. The coroner stated that the preliminary autopsy notes that the patient "was found in his unlocked one room apartment in rooming house. He is in a decomposed state. A subcutaneous pacer observed and seizure medications found in room. " the preliminary autopsy notes that the cause of death is pending further study. The autopsy is not completed at this time, however, the manufacturer is to be notified of the results when completed. The explanted lead and generator have been returned to manufacturer where analysis is underway. Further follow-up with the patient's treating neurologist revealed that the physician does not manage the vns device and only manages the patient's seizure medications. The nurse was not aware of the name of the physician who does manage the patient's device, and attempts to obtain this information from the neurologist have been unsuccessful to date. There is no programming or diagnostic history available to the manufacturer. The nurse stated that the patient was seen last on (b)(6) 2010, where the physician noted that the patient was "fine" at that time. A sudep evaluation performed by the manufacturer has preliminarily determined the death to be possible sudep.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__id=1754808
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dennis100
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« Reply #4 on: February 24, 2019, 03:11:51 AM »

Model Number 103
Event Date 11/16/2011
Event Type  Death   
Manufacturer Narrative

Event Description
It was reported that the patient passed away. No other details given. Attempts for further information have been unsuccessful to date.
 
Event Description
Additional information was received from the physician indicating that the death was not witnessed and no details are available regarding the exact cause of death, but the physician does not feel the death is related to vns. The patient had a reduction in seizures with vns and was receiving therapy at the time of death. Then patient was compliant with aeds, but was "poorly compliant with required follow-up and maintenance visits", per physician. This death event has been reviewed by manufacturer nurse and with the available information has been determined to be possible sudep.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2378374
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dennis100
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« Reply #5 on: February 24, 2019, 03:12:24 AM »

Model Number 101
Event Date 12/29/2008
Event Type  Death   
Event Description
It was reported that the patient was deceased. No cause of death or other information was given. Attempts for further information have been unsuccessful to date.
 
Event Description
This death event has been reviewed by a manufacturer nurse and with the available information has been determined to be possible sudep. The patient had epilepsy and died, but no other information is known. As such, sudep cannot be ruled out as a possible cause of death. Attempts for further information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2403060
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dennis100
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« Reply #6 on: February 24, 2019, 03:13:33 AM »

Model Number 102R
Event Date 01/20/2015
Event Type  Death   
Manufacturer Narrative

Manufacturer Narrative
Review of the available programming and diagnostic history.
 
Event Description
It was reported that the vns patient passed away on (b)(6) 2015. The cause of death and its relationship to vns are unknown. The patient¿s device was explanted and was returned to the manufacturer for analysis. Monitoring of the device output signal showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current. The pulse generator diagnostics were as expected for the programmed parameters. The device performed according to functional specifications. Analysis concluded proper functionality of the pulse generator and that no abnormal performance or any other type of adverse condition was found. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. There is no evidence to suggest an anomaly with the returned portions of the device. Note that since the lead assembly (body) including the electrode array section was not returned for analysis, an evaluation cannot be made on that portion of the lead. Attempts for additional relevant information have been unsuccessful to date. Based on the limited available information about the patient¿s death, an internal classification has determined that the death may be possible sudep.
 
Event Description
Death certificate was received on (b)(6) 2015 and indicated the following additional information. The patient¿s place of death was in the hospital. Disposition of the deceased was burial. Manner of death was not indicated. Cause of death was respiratory failure (minutes) / status epilepticus (days)/ sepsis (days)/ urinary tract infection (days). Other significant conditions contributing to death were indicated as profound mental retardation, history of stroke, seizures. Autopsy was not performed. Programming history was reviewed for the patient¿s device. The last known settings system diagnostics were from (b)(6) 2010 and were within normal limits.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4699334
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dennis100
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« Reply #7 on: February 24, 2019, 03:14:11 AM »

Model Number 103
Event Date 10/22/2013
Event Type  Death   
Manufacturer Narrative
Analysis of programming history.
 
Event Description
On (b)(6) 2014, this patient death was reported. The death was attributed to sudep. Follow-up showed that the patient was seizure free was vns therapy. Settings were provided up to (b)(6) 2013, but no other information regarding the patient¿s death was known. Review of programming history showed that the last diagnostics are from (b)(6) 2012 and were within normal limits. An in-house sudep evaluation showed possible sudep. Review of online obituaries showed the date of death to be (b)(6) 2013. Follow-up with the funeral home showed that the patient was buried with the device.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3667938
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dennis100
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« Reply #8 on: February 24, 2019, 03:14:48 AM »

Model Number 102R
Event Date 04/27/2009
Event Type  Death   
Event Description
Reporter indicated a vns pt died and the death was not related to the vns. The pt was at home in his room at the time of the death and was found by his mother. The pt was receiving vns therapy at the time of death. An autopsy was not performed and the vns device was not explanted. With the available information, the manufacturer has determined that the death was probable sudep. Attempts for the death certificate are in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__id=1412361
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dennis100
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« Reply #9 on: February 24, 2019, 03:15:50 AM »

Model Number 102
Event Date 03/12/2016
Event Type  Death   
Event Description
Additional information was received that the patient had passed away on (b)(6) 2016. The patient's devices were explanted on (b)(6) 2016 by the medical examiner's office but have not been received to date. Patient was re-admitted in to (b)(6) hospital around (b)(6) 2016 due to experiencing seizures. After seizures, patient clutches the generator site and complained of pain. According to the treating physician, this has occurred several times. The hospital requested the device be checked and a field representative performed interrogation and diagnostics. The physician was informed about using the magnet to disable the patient's device and was asked to contact the patient's neurologist for further instruction. An internal sudep evaluation was performed by the manufacturer which determined the death to be possible sudep. The autopsy results were requested from the medical examiner's office but were not received to date as the autopsy is not yet completed.
 
Event Description
Death certificate and the autopsy results were received indicating that the patient's immediate cause of death was hypertensive cardiovascular disease. The manner of death is natural. The patient died while in hospice care. Patient's medical history is significant for congestive heart failure, liver and kidney failure, (b)(6), mental retardation and dementia. Patient also has a clinical history of seizure disorder. Per the autopsy results, the heart is markedly enlarged and globular with four-chamber dilatation and diffuse endocardial fibrosis of the left ventricle. The lungs are edematous, and the right lower lung lobe is collapsed, the liver is mottled. The right kidney has marked cortical pitted scars consistent with remote infarction or possible chronic pyelonephritis. A vagus nerve stimulator is in place. As such, the cause of death is hypertensive cardiovascular disease. Hepatitis c is a contributory cause.
 
Manufacturer Narrative

Event Description
The explanted devices were received for analysis on 05/02/2016. Since a significant portion of the lead (including the electrode array) was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portion. Analysis of the generator is underway and has not been completed to date.
 
Manufacturer Narrative
Additional manufacturer narrative and/or corrected data: supplemental report #1 inadvertently omitted the identifiers of the corrected data fields, which were (describe event or problem) and (relevant tests/laboratory data, including dates) regarding details of the patient¿s hospital admission and device diagnostics respectively.
 
Event Description
It was reported that the patient was admitted to the icu due to seizures. The nurse at the icu reported that the patient grabs at the area of vns but is unable to communicate the issue due to pre-existing conditions. Due to this, a device issue is suspected and the nurse was informed about the use of magnet in disabling the stimulation and referred to patient's neurologist who can disable the device. Additional information was received from the nurse at the icu about patient's admission on (b)(6) 2016 due to nausea and vomiting. On (b)(6) 2016, patient experienced seizures. At night around 1 pm on (b)(6) 2016, patient grabbed the left chest at the generator site and reported pain. Patient was given pain medication and the magnet was not used to disable the device. On (b)(6) 2016, patient reported pain again around 4 pm. Patient was reported to have been discharged after (b)(6).
 
Event Description
In the (b)(4) lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generatoroutput signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. Analysis in the (b)(4) lab concluded proper functionality of the pulse generator and that no abnormal performance or any other type of adverse condition was found.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5549413
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dennis100
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« Reply #10 on: February 24, 2019, 03:16:43 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/10/2015
Event Type  Death   
Manufacturer Narrative

Event Description
The patient's generator and lead were returned to the manufacturer, and product analysis was completed for the generator. Monitoring of the device output signal showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current. The pulse generator diagnostics were as expected for the programmed parameters. Other than findings attributed to the device explant procedure, no visual anomalies were found on the generator. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The internal device data revealed that 59. 735% of the battery had been consumed and no anomalies were contained. Analysis of the returned lead is currently underway. No additional pertinent information has been received to date.
 
Event Description
It was reported that the patient passed away. An online obituary search determined the date of death was (b)(6) 2015. Information from the funeral home indicates the cause of death was respiratory failure, but no information was provided on what led to the respiratory failure or the circumstances of death. The relationship of the patient's death to vns therapy is unknown. Review of programming and diagnostic history showed normal diagnostic results through (b)(6) 2012. Based on the limited available information about the patient's death, an internal classification has determined that the death may be possible sudep. The device was explanted, but has not been returned to date. No additional pertinent information has been received to date.
 
Event Description
Product analysis of the patient's returned lead portion was completed. No electrical discontinuities were identified within the returned lead portion. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portion. No adverse effect was identified on the device performance. Note that since a portion of the lead including the electrode array was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. No additional pertinent information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5358583
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dennis100
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« Reply #11 on: February 24, 2019, 03:18:24 AM »

Model Number 102
Event Date 08/16/2013
Event Type  Death   
Event Description
It was reported by the physician that the patient had died. Follow up found that the date of death was (b)(6) 2013. It was reported that the aptient was found in the bathroom after an apparent seizure. The patient had incontinence. The family was insistent that the patient had not missed any medication and there was no known cause for a seizure. They do not plan for an autopsy. Good faith attempts have been made; however, they have been unsuccessful. No additional information has been provided.
 
Manufacturer Narrative
Date received by manufacturer; corrected date: previously submitted mdr inadvertently provided a wrong date for this field (08/25/2014). The correct date for this field is 09/02/2014. This report is being submitted to correct this date.
 
Event Description
Additional information was received indicating that the vns patient had passed away from "natural causes¿. The coroner noted bruising on the left eyelid and bruising and swelling of the tongue, which indicates that the patient possibly had a seizure and bit his tongue prior to death. An autopsy was not performed and a blood sample was not ordered. The cause of death was listed as ¿seizure¿. The coroner¿s report noted that the patient had a history of seizures and was implanted with a vns device. It is believed that the patient¿s device was not explanted prior to burial; therefore, no analysis can be performed. With the available information, an internal classification has determined that the death may be possible sudep.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=3350634
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dennis100
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« Reply #12 on: February 24, 2019, 03:18:57 AM »

Model Number 101
Event Date 04/09/2009
Event Type  Death   
Event Description
It was reported to manufacturer that the vns pt passed away. Further follow up with the pts treating vns neurologist, revealed that the "pt was taking a nap. Mom went in to check on him, and he was not breathing. Mom called ems". The physician noted that the device was not explanted, not available from the physician's office. The pt was on the following aed's at the time of death: phenytoin, clonazepam, trileptal, zonegran, and lyrica. The pt was receiving vns therapy at the time of death. The physician does not believe that the death is related to vns therapy. Attempts to obtain the death certificate from the vital records department have been made, but no information has been received to date. The manufacturer has determined the death to be probable sudep.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1392583
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dennis100
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« Reply #13 on: February 24, 2019, 03:20:17 AM »

Model Number 102R
Event Date 05/02/2013
Event Type  Death   
Event Description
It was reported that the patient passed away approximately 3-4 months ago. The cause of death is not know at this time. It was reported that the patient had a pacemaker and known cardiac issues which was previously reported in mfr. Report # 1644487-2013-00834. Attempts to obtain additional information will be made, but no information has been obtained to date.
 
Event Description
Analysis of the returned generator and lead was completed. There were no performance or any other type of adverse conditions found with the pulse generator. The device was confirmed to be at end of service as result of normal battery depletion. The depletion was an expected event as determined by the blc and battery voltage measurement. The module performed according to functional specifications. There is no evidence to suggest an anomaly with the returned portions of the lead. During the visual analysis, the (+) white and (-) green electrodes appeared to be embedded in what appeared to be remnants of dried body tissue. This condition may have prevented the ribbons from coming in contact with the vagus nerve. With the exception of the tissue-covered (+) white and (-) green electrodes, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The setscrew marks found on the lead connector pins provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no discontinuities were identified. Note that since a large portion of the lead assembly (body) was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.
 
Event Description
Additional information was received stating that the vns patient¿s device was at end of service on (b)(4) 2010.
 
Manufacturer Narrative

Event Description
Additional information was received stating that the vns patient passed away on (b)(6) 2013. The patient was found dead on his bed in a supine position. The patient device¿s was disabled at the time of death and was not explanted. It was reported that the patient¿s death was not related to vns. An internal review of the available information determined that the patient¿s death was possible sudep.
 
Manufacturer Narrative
Additional information indicates that the patient¿s dob was (b)(6) 1946.
 
Event Description
Additional information was received stating that the vns patient was born on (b)(6) 1946, not (b)(6) 1949 as initially reported. The patient¿s death certificate was obtained. The death certificate listed the immediate cause of death as cardiopulmonary arrest with probable acute coronary syndrome and probable coronary artery disease as sequential conditions that contributed to the death. The patient had other significant health conditions may have contributed to the patient¿s condition. Nurse¿s notes regarding the patient¿s death were received. The notes indicate that the patient was being closely monitored due to treatment with continuous positive airway pressure (cpap). It was noted that the patient¿s cpap mask had be adjusted frequently. No issues were noted with the patient when he was evaluated at 11:00 pm on (b)(6) 2013. At 11:45 pm, the notes indicate that nurse required assistance adjusting the patient¿s cpap mask because the patient kept removing it. At midnight, nurse reported that the patient was pale, warm to touch, breathless, non-responsive, and pulseless. Cpr was immediately initiated and the paramedics that arrived approximately ten minutes later continued cpr until the patient was pronounced dead at 12:33 am on (b)(6) 2013. Follow-up with the nurse revealed that the patient was not having a seizure at the time of death the patient¿s seizure record indicated that the patient experienced several seizures from (b)(6) 2013 which consisted of stiffening, jerking, some forward head drops, flinging of the arms. The patient¿s postictal periods were uneventful with good recovery. With the available information, an internal classification determined that the death was unlikely sudep. The patient¿s body was donated to science and the patient¿s devices were explanted. The explanted generator and lead have been returned to the manufacturer where analysis is currently underway.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3506710
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dennis100
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« Reply #14 on: February 24, 2019, 03:21:12 AM »

Event Type  Death   
Manufacturer Narrative

Event Description
It was reported that the vns patient passed away. It was reported that the patient had been implanted with vns for many years and she died suddenly. It was reported that the emergency services were called by the patient¿s family and they were advised to initiate resuscitation maneuvers on the patient. It was reported that the paramedics used an automatic external defibrillator when they arrived. The automated external defibrillator did not advice to deliver any shocks. Further information was received stating that, on the date of death, the patient had indicated to her spouse that she felt unwell. Around 11:30 pm the patient suffered a severe seizure while in bed. Approximately one hour later, including the post-ictal period, the patient and the spouse fell asleep. Around 3:00 am the patient¿s spouse woke up and attempted to wake up the patient, but she did not react. The spouse requested medical aid and resuscitation maneuvers were started by family members. Upon arrival of the paramedics, an automated external defibrillator was used. The automated external defibrillator advised to continue with resuscitation and it did not advise to deliver shocks. It was reported that asystole was suspected. The resuscitation attempts were unsuccessful and the patient passed away. Based on the limited available information about the patient¿s death, an internal classification has determined that the death may be probable sudep. Attempts to obtain further information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4952029
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dennis100
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« Reply #15 on: February 24, 2019, 03:21:47 AM »

Model Number 101
Event Date 10/09/2009
Event Type  Death   
Event Description
It was reported that the pt died in 2009 at his group home. Per reporter, the pt was found by his attendant, nude in a dry bathtub, and was dry to the touch. Pt was transported to the hospital, but was pronounced dead. The death was not witnessed. Per the reporter, the pt's vns was turned off at the time of death. Follow-up with the medical examiner reveals that the cause of death is undetermined at this time. Based on the info received to date, the event has been determined to be a possible sudep by a manufacturer medical professional. The product was explanted from the pt and returned to manufacturer, but analysis is pending. A voluntary medwatch was submitted to fda regarding this event. Attempts to contact treating physician for further info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__id=1581925
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dennis100
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« Reply #16 on: February 24, 2019, 03:22:36 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/18/2016
Event Type  Death   
Event Description
It was reported that the patient had passed away, as confirmed through an online obituary. She was found unresponsive by the nursing staff at her care facility after a possible seizure. Cpr was attempted, but the patient had expired. The patient was previously in the hospital the week before her passing for blood clots, and was transferred to a skilled nursing facility after being in the hospital for a few days. The device history records of the lead and generator were reviewed and found that all specifications were met prior to distribution. Based on the limited available information about the patient¿s death, an internal classification has determined that the death may be possible sudep. No additional pertinent information has been received to date.
 
Manufacturer Narrative

Event Description
The county coroner showed that the patient¿s death was reported to them, but they did not handle the patient¿s case and had no autopsy report on it. Communications with the office of the treating physician showed that the patient¿s family was requesting an autopsy. The office confirmed that no warnings for abnormal impedance were seen in the last office visit. The patient¿s treating rehabilitation center reported that in the days preceding her death, the patient was diagnosed with dilantin toxicity. The patient then had a seizure and was also found to be very hypoxic. Computed tomography angiography (cta) showed many pulmonary embolisms. The patient was started on a lovenox/coumadin bridge, and her dilantin dose was decreased. Once patient was medically stable, she was transferred to the rehabilitation center. The next day, the patient had a witnessed seizure and appeared to be stable following the seizure. Approximately one hour later, the patient was found pulseless in her room. She was rushed to the hospital and had cpr performed without success. The patient was pronounced dead by the hospital emergency department. No additional pertinent information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6252764
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« Reply #17 on: February 24, 2019, 03:23:18 AM »

Model Number 102R
Event Date 02/11/2013
Event Type  Death   
Manufacturer Narrative

Event Description
It was reported that the vns patient passed away on (b)(6) 2013. No autopsy was performed and the patient¿s device was not explanted. The believed cause of death was listed as pneumonia, sepsis question of lung cancer. It was noted that the patient achieved seizure reduction with vns; however, the relationship between the death and vns is unknown. Based on the available information about the patient¿s death, an internal classification has determined that the death may be possible sudep.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4278067
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dennis100
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« Reply #18 on: February 24, 2019, 03:24:02 AM »

Event Date 05/23/2011
Event Type  Death   
Event Description
It was reported that the pt had passed away. The physician has not seen this pt in a long time and the pt was being followed by an unk physician, so the details surrounding death are unk at this time.
 
Event Description
Evaluation by a manufacturer nurse reveals that the patient's death is a possible sudep. Attempts for further information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2180777
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dennis100
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« Reply #19 on: February 24, 2019, 03:25:22 AM »

Model Number 102
Device Problem Insufficient Information
Event Date 06/11/2012
Event Type  Death   
Event Description
Cause of death information obtained from the national death index (ndi) was reviewed by the manufacturer which indicated that the patient passed away on (b)(6) 2012 and the patient's underlying cause of death was potential sudep. The cause of death per the ndi was infantile cerebral palsy, sleep apnea, encephalopathy, and other unspecified convulsions. A sudep (sudden unexpected death in epilepsy) evaluation was performed which determined that the death met criteria for classification of possible sudep. There is no allegation or other information indicating that the death is related to vns.
 
Event Description
On (b)(6) 2012, the vns patient's mother reported that the patient passed away last night. The mother mentioned that the patient was having seizures, but no indication of an increase. Good faith attempts to the physician for further information were made but no additional information was received. The department of state health in the state the patient passed away in reported that they will not provide death certificates to the manufacturer. A review of the patient's programming history revealed that the patient was last programmed to output=2. 75ma/frequency=30hz/pulse width=250usec/on time=30sec/off time=0. 8min/magnet output=3ma/magnet pulse width=250usec/magnet on time=60sec on (b)(6) 2011. A battery life calculation was performed which showed 0. 34 years remaining until the elective replacement indicator flagged as "yes. " with the available information provided to the manufacturer thus far, the patient's death has been determined to be possible sudep.
 
Manufacturer Narrative
Analysis of programming history.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2639930
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dennis100
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« Reply #20 on: February 24, 2019, 03:26:24 AM »

Event Date 12/01/2011
Event Type  Death   
Event Description
Further information was received from the treating nurse indicating that no additional information was available regarding the reported events. This death event has been reviewed by the manufacturer and with the available information has been determined to be possible sudep. The only known factors are that the patient had epilepsy and died. As such, sudep cannot be ruled out as a cause of death.
 
Manufacturer Narrative

Event Description
It was reported by a company representative that a vns patient had passed away on (b)(6) 2011. The patient had not been seen for follow up visits since 2005, and was reported to be experiencing an increase in tonic clonic seizures. The patient was seen by a new physician in (b)(6) 2011 and a new aed was introduced. At the moment, the cause of death is unknown as the coroner has very few details and an autopsy is not available. Good faith attempts to obtain further information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2389547
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dennis100
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« Reply #21 on: February 24, 2019, 03:27:07 AM »

Event Date 05/18/2015
Event Type  Death   
Manufacturer Narrative

Event Description
It was reported that the vns patient passed away on (b)(6) 2015 from natural causes. The cause of death and its relationship to vns are unknown. No autopsy was performed and the patient¿s device was not explanted prior to burial. Attempts for additional relevant information have been unsuccessful to date. Based on the limited available information about the patient¿s death, an internal classification has determined that the death may be possible sudep.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4859679
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dennis100
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« Reply #22 on: February 24, 2019, 03:27:48 AM »

Event Type  Death   
Manufacturer Narrative

Event Description
It was reported that the vns caregiver was told by an unknown physician that there were three cases where pediatric patients had passed away due to cardiac arrest from vns. Attempts for additional relevant information have been unsuccessful to date. Based on the limited available information about the patients¿ deaths, an internal classification has determined that the deaths may be possible sudep.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4838774
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dennis100
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« Reply #23 on: February 24, 2019, 03:28:24 AM »

Model Number 103
Event Date 04/01/2015
Event Type  Death   
Manufacturer Narrative
Review of the available programming and diagnostic history.
 
Event Description
It was reported that the vns patient passed away in (b)(6) 2015. The cause of death and its relationship to vns are unknown. Attempts for additional relevant information have been unsuccessful to date. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2013. A battery life calculation using the available programming history showed > 10 years remaining. Based on the limited available information about the patient¿s death, an internal classification has determined that the death may be possible sudep.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4824699
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dennis100
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« Reply #24 on: February 24, 2019, 03:29:05 AM »

Model Number 102
Event Date 05/20/2014
Event Type  Death   
Manufacturer Narrative

Event Description
It was reported that the vns patient passed away on (b)(6) 2014. The cause of death and its relationship to vns are unknown. No further information relevant to the death has been received to date. Based on the limited available information about the patient¿s death, an internal classification has determined that the death may be possible sudep.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4775834
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dennis100
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« Reply #25 on: February 24, 2019, 03:29:36 AM »

Model Number 102R
Event Type  Death   
Event Description
It was reported that the patient had passed away about a year prior per the neurologist. Follow-up with the neurologist revealed that the patient had not been seen for approximately eight years, and the cause of death was unknown. No additional information was provided by the neurologist. Follow-up with the county of residence coroner¿s office was performed, but they were unable to locate information regarding the patient¿s death. (b)(6) attempts for additional relevant information have been unsuccessful. With the available information, the death was reviewed by the manufacturer and classified as possible sudep.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4743812
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dennis100
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« Reply #26 on: February 24, 2019, 03:30:20 AM »

Model Number 102
Event Date 06/04/2012
Event Type  Death   
Manufacturer Narrative
Analysis of programming history performed.
 
Event Description
On (b)(6) 2013 a sudep evaluation was performed by the manufacturer with the information available and it was determined that the patient¿s death is considered to be possibly sudep related.
 
Event Description
Cause of death information obtained from the national death index (ndi) was reviewed by the manufacturer which indicated that the patient passed away on (b)(6) 2012 and the patient's cause of death was: atherosclerotic heart disease; benign neoplasm of adrenal gland; myocardial degeneration; cardiomegaly; atherosclerosis of aorta. There is no allegation or other information indicating that the death is related to vns.
 
Event Description
It was reported that the patient had not been seen in a long time, and the treating physician was unknown. The company case manager searched online and found an obituary for the patient who passed away on (b)(6) 2012. The reason is unknown. The patient¿s previously treating physician moved a few years prior and no longer practices vns. The patient passed away outside of his care. Review of the company programming history database revealed the patient¿s last programming physician was another physician (on (b)(6) 2010). Attempts for additional information from this physician have been unsuccessful to date.
 
Event Description
Follow-up with the funeral home was done and they did not have the generator or lead for return.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3205872
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dennis100
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« Reply #27 on: February 24, 2019, 03:31:00 AM »

Model Number 104
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/09/2015
Event Type  Death   
Event Description
Follow-up to the physician at the patient's group home revealed the patient's cause of death was respiratory failure, restrictive lung disease due to scoliosis, and aspiration pneumonia due to dysphagia. The physician stated that vns did not contribute to the dysphagia or the cause of death.
 
Manufacturer Narrative
Suspect device udi: (b)(4).
 
Event Description
It was reported that the vns patient passed away on (b)(6) 2015. The cause of death and its relationship to vns are unknown. It was noted that the patient had been hospitalized the past month due to fever and aspiration unrelated to vns. No further information relevant to the event has been received to date. Based on the limited available information about the patient¿s death, an internal classification has determined that the death may be possible sudep.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4889279
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dennis100
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« Reply #28 on: February 24, 2019, 03:31:43 AM »

Model Number 104
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/09/2015
Event Type  Death   
Event Description
Follow-up to the physician at the patient's group home revealed the patient's cause of death was respiratory failure, restrictive lung disease due to scoliosis, and aspiration pneumonia due to dysphagia. The physician stated that vns did not contribute to the dysphagia or the cause of death.
 
Manufacturer Narrative
Suspect device udi: (b)(4).
 
Event Description
It was reported that the vns patient passed away on (b)(6) 2015. The cause of death and its relationship to vns are unknown. It was noted that the patient had been hospitalized the past month due to fever and aspiration unrelated to vns. No further information relevant to the event has been received to date. Based on the limited available information about the patient¿s death, an internal classification has determined that the death may be possible sudep.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4889279
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dennis100
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« Reply #29 on: February 24, 2019, 03:32:25 AM »

Model Number 102
Event Date 08/04/2006
Event Type  Death   
Manufacturer Narrative

Event Description
It was reported that the patient passed away on (b)(6) 2016. She was found deceased in her home. The physician reported that the patient had cps and gtc seizures along with morbid obesity and depression. The patient was presumably seizure free, according to the physician's report. An autopsy was not performed, but the generator and lead were explanted and discarded. The patient's last visit to her physician was on (b)(6) 2006, and the patient was receiving vns therapy at the time of death to the physician's knowledge. The patient was on topimate and lamotrigine at the time of death. The relationship of the death and vns was unknown since the cause of death was unknown, but the physician did not attribute the death to vns. Additional information was received from the national death index. The cause of death was: major cardiovascular disease, generalized and unspecified atherosclerosis, other obesity, unspecified depressive episode, unspecified epilepsy, unspecified asthma, and unspecified arthrosis. A sudep (sudden unexpected death in epilepsy patients) evaluation was performed based on information from the national death index, and the death was determined to be probable sudep.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5983626
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