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dennis100
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« on: May 07, 2014, 11:38:25 AM »

Model Number 102
Event Date 10/01/2006
Event Type Other
Patient Outcome Other
Event Description
Reporter stated that patient was found dead in their bed by caregiver. Cause of death is unknown and no autopsy will be done. Manufacturer has determined that sudep is probable. The reporter has stated the ncp system was unrelated to the death.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=773005
« Last Edit: September 24, 2015, 07:28:36 AM by dennis100 » Logged
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« Reply #1 on: May 07, 2014, 12:03:26 PM »

Model Number 101
Event Date 01/20/2007
Event Type Other
Patient Outcome Other
Manufacturer Narrative
Reporter stated the ncp system was unrelated to the death event.

Event Description
Reporter stated patient was found dead in their bed by caregiver. Cause of death is unknown; an autopsy is pending. Manufacturer has determined that sudep is probable. Product analysis of the returned generator and lead found no anomalies that could have caused or contributed to the death event. The reporter has stated the ncp system was unrelated to the death.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=831124
« Last Edit: September 24, 2015, 07:29:04 AM by dennis100 » Logged
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« Reply #2 on: May 07, 2014, 12:04:37 PM »

Model Number 103
Event Date 10/26/2008
Event Type Death
Patient Outcome Death
Event Description
Reporter indicated that the patient was found unresponsive and later passed away. Per reporter, patient had a lot of neurological problems, but was doing well with vns with respect to seizures. An autopsy was performed and the autopsy report was obtained by the manufacturer. X-rays were taken and no anomalies were noted. The autopsy report noted the patient died of natural causes ascribed to a seizure disorder due to cerebral palsy. Due to the autopsy being an external examination versus complete autopsy and the circumstances surrounding the patient death, the manufacturer has classified this death as a probable sudep event. Product has been requested, but has not been received to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1246223
« Last Edit: September 24, 2015, 07:29:41 AM by dennis100 » Logged
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« Reply #3 on: May 07, 2014, 12:05:32 PM »

Model Number 101
Event Date 04/09/2009
Event Type Death
Patient Outcome 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.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1392583
« Last Edit: September 24, 2015, 07:30:05 AM by dennis100 » Logged
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« Reply #4 on: May 07, 2014, 12:06:18 PM »

Model Number 102R
Event Date 04/27/2009
Event Type Death
Patient Outcome 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.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__id=1412361
« Last Edit: September 24, 2015, 07:30:32 AM by dennis100 » Logged
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« Reply #5 on: May 07, 2014, 12:07:24 PM »

Model Number 101
Event Date 10/09/2009
Event Type Death
Patient Outcome 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.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__id=1581925
« Last Edit: September 24, 2015, 07:31:10 AM by dennis100 » Logged
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« Reply #6 on: May 07, 2014, 12:08:30 PM »

Model Number 101
Event Date 06/10/2010
Event Type Death
Patient Outcome 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.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__id=1754808
« Last Edit: September 24, 2015, 07:31:59 AM by dennis100 » Logged
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« Reply #7 on: February 06, 2015, 06:06:31 AM »

Model Number 101
Event Date 08/15/2009
Event Type Death
Manufacturer Narrative
The physician stated the death was unrelated to vns however, as the death is a definite sudep, the exact cause of death and the relationship to vns remains unclear.

Event Description
It was initially reported that a patient passed away. The cause of death was believed to be seizure related and unrelated to the patient¿s vns device. Follow-up with the county where the patient passed away revealed that the patient was found dead on his bedroom floor by his caregiver. An hour prior to the death, the caregiver checked in on the patient and thought he was lying awake in the bed and was making an unusual ¿snoring¿ sound. Thirty minutes later, the caregiver checked in on the patient again, and the patient appeared to be sleeping in the bed. Thirty minutes after that, the caregiver found the patient lying supine on the bedroom floor. There was no evidence of trauma or that the patient choked on anything. The patient was pronounced dead thirteen minutes later. The patient was taking multiple medications prior to his death which included: oxcarbazepine, banzel, topamax, dilantin, folic acid, clonazepam, glycolax, pericolace, and fibercon. An autopsy was performed and the cause of death was listed as cerebral palsy with refractory seizures (epilepsy). The manner of death was listed as natural. An internal sudep evaluation was performed and the death was determined to be a definite sudep.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4436716
« Last Edit: September 24, 2015, 07:32:28 AM by dennis100 » Logged
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« Reply #8 on: February 06, 2015, 06:07:08 AM »

Model Number 102
Event Date 07/15/2005
Event Type Death
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.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4398028
« Last Edit: September 24, 2015, 07:32:54 AM by dennis100 » Logged
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« Reply #9 on: February 16, 2015, 03:10:26 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.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4278067
« Last Edit: September 24, 2015, 07:33:17 AM by dennis100 » Logged
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« Reply #10 on: February 16, 2015, 03:11:01 AM »

Model Number 103
Event Date 06/04/2011
Event Type Injury
Patient Outcome Death
Manufacturer Narrative

Event Description
On (b)(6), 2012 it was reported that the vns patient passed away last year. No further information was provided at the time. Currently there is not enough information to rule out sudp as a possible cause of death, therefore the death is concluded possible sudep at this time. Good faith attempts for further information from the physician's nurse have been made but have been unsuccessful. A copy of the patient's death certificate cannot be obtained as the manufacturer does not meet the eligibility requirements of who is allowed to obtain a copy of a patient's death certificate in the state the patient passed away in.

Event Description
Additional information was received on (b)(6) 2012, when the physician's nurse reported that the patient's cause of death is unknown but was unrelated to vns. The patient's concurrent illnesses or diseases were noted to be post-traumatic epilepsy, fracture of subdural hematoma (1999), history of nonconvulsive status epilepticus. The patient had continued seizures with vns therapy. The patient was still receiving vns therapy at the last office visit; output=1ma/frequency=25hz/pulse width=250usec/on time=30sec/off time=5min/magnet output=1. 25ma/magnet on time=60sec/magnet pulse width=250usec. The patient was noted to have passed away on (b)(6) 2011. It was unknown if the vns was explanted after the patient's death. They did not have any recent laboratory reports or findings considered relevant to the cause of death. No death certificate was provided. It was unknown if the patient's death was witnessed. The patient was (b)(6) upon epilepsy onset. The patient did not have a history of febrile seizures. The patient had second generalized seizures and complex partial seizures. The patient has never undergone resective epilepsy surgery. At the time of death (by phone report on (b)(6) 2011), the patient was taking keppra, dilantin, phenobarbital, keonopinic, and tegrete and the patient was noted to be compliant with aeds. The patient's obituary was found online which stated that the patient's date of death was (b)(6) 2011. The patient's death was determined to be a possible sudep with the information received to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2742866
« Last Edit: September 24, 2015, 07:35:15 AM by dennis100 » Logged
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« Reply #11 on: February 16, 2015, 03:11:28 AM »

Event Date 01/27/2006
Event Type Other
Patient Outcome Other;
Event Description
Further evaluation of available information indicates that the patient death was possibly due to sudep (sudden unexplained death in epilepsy).

Event Description
Reporter indicated that pt had passed away. It was reported that the pt was residing in a nursing home and that the staff found him expired in his bed during the night. The pt reportedly experienced a 25% reduction in seizures with the vns therapy and was receiving therapy at the time of death.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=695685
« Last Edit: September 24, 2015, 07:35:55 AM by dennis100 » Logged
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« Reply #12 on: February 16, 2015, 03:11:53 AM »

Event Type Death
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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« Reply #13 on: February 16, 2015, 03:12:24 AM »

Model Number 102
Event Date 06/04/2009
Event Type Death
Patient Outcome Death;
Event Description
It was initially reported that the patient past away a long time ago. It is unclear is the death was related to vns. There was no further information that was provided as the physician deleted her file and she was no longer in their system. The physician was not willing to give any additional information. Based on the information the patient's death may be a possible sudep.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2382637
« Last Edit: September 24, 2015, 07:38:01 AM by dennis100 » Logged
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« Reply #14 on: February 16, 2015, 03:12:48 AM »

Model Number 103
Event Date 11/16/2011
Event Type Death
Patient Outcome 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.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2378374
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« Reply #15 on: February 16, 2015, 03:13:14 AM »

Model Number 102
Event Date 06/09/2005
Event Type Death
Patient Outcome 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 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.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2405539
« Last Edit: September 24, 2015, 07:39:16 AM by dennis100 » Logged
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« Reply #16 on: February 16, 2015, 03:13:38 AM »

Event Date 05/26/2011
Event Type Death
Patient Outcome Death;
Event Description
It was reported that the pt had passed away on (b)(6) 2011. The physician is attributing the death to sudep, but it is unk how or why the physician came to that conclusion. The pt died in her sleep. The pt was last seen by physician on (b)(6) 2010 and eri was no on this date (other diagnostics/settings are unk). Evaluation by manufacturer nurse reveals that the event is a probable sudep. Attempts for further information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2229026
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« Reply #17 on: February 16, 2015, 03:14:02 AM »

Event Date 09/15/2080
Event Type Death
Patient Outcome Death;
Event Description
Reporter indicated a patient died at home the same evening after being released from the hospital following vns generator replacement surgery. The vns was programmed off. The death was not witnessed and the patient was found dead by her mother. The reporter has stated the vns was unrelated to the death. No autopsy will be performed. It is unknown if the patient was buried with the vns. The manufacturer has determined the death was probable sudep.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1213932
« Last Edit: September 24, 2015, 07:40:38 AM by dennis100 » Logged
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« Reply #18 on: February 16, 2015, 03:14:27 AM »

Model Number 101
Event Date 12/29/2008
Event Type Death
Patient Outcome 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.

Manufacturer Narrative

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.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2403060
« Last Edit: September 24, 2015, 07:41:03 AM by dennis100 » Logged
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« Reply #19 on: February 16, 2015, 03:14:52 AM »

Model Number 102
Event Type Death
Patient Outcome Death
Manufacturer Narrative

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.

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.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2378305
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« Reply #20 on: February 16, 2015, 03:15:17 AM »

Event Date 03/17/2011
Event Type Death
Patient Outcome Death;
Event Description
On (b)(6), 2011, the country manager of (b)(4) reported that the vns pt had passed away that night during sleep. Info received states that the pt's vns will not be explanted, therefore, no product analysis can be performed on the pt's vns. According to the physician, the pt's death is not related to vns. The pt passed away during sleep and his mother found him the next day. No autopsy was performed and the death was not witnessed. A sudep eval was performed and it was determined to be a probable sudep case. It is unk if death was caused by a seizure or status epilepticus. If add'l info is received, it will be reported.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2055660
« Last Edit: September 24, 2015, 07:42:03 AM by dennis100 » Logged
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« Reply #21 on: February 16, 2015, 03:15:40 AM »

Event Date 05/12/2011
Event Type Death
Patient Outcome Death;
Event Description
Our consultant in the (b)(6) was contacted by a vns treating physician reporting that they had a vns patient who had died suddenly. Their death was reported to be not vns related but no circumstances around the death were provided. The patient did not have an autopsy performed and their death was not witnessed. Their explanted products are being returned for analysis. Their device was programmed on at the time of death and they had a 50% reduction in their seizures. Based on the circumstances of the death reported it is probable sudep.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2119831
« Last Edit: September 24, 2015, 07:42:55 AM by dennis100 » Logged
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« Reply #22 on: February 16, 2015, 03:16:14 AM »

Event Date 10/26/2006
Event Type Other
Patient Outcome Other;
Event Description
Reporter stated that patient was found dead in their bed by caregiver. Cause of death is unknown and no autopsy will be done. Manufacturer has determined that sudep is probable. The reporter has stated the ncp system was unrelated to the death.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=785944
« Last Edit: September 24, 2015, 07:43:16 AM by dennis100 » Logged
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« Reply #23 on: February 16, 2015, 03:16:38 AM »

Event Date 05/23/2011
Event Type Death
Patient Outcome Death
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.

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.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2180777
« Last Edit: September 24, 2015, 07:43:39 AM by dennis100 » Logged
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« Reply #24 on: February 16, 2015, 07:26:37 AM »

Event Date 12/01/2011
Event Type Death
Patient Outcome Death,Required Intervention
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.

Manufacturer Narrative

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.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2389547
« Last Edit: September 24, 2015, 07:44:22 AM by dennis100 » Logged
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« Reply #25 on: February 16, 2015, 07:27:29 AM »

Model Number 102
Event Date 06/11/2012
Event Type Death
Patient Outcome Death
Manufacturer Narrative
Analysis of programming history.

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.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2639930
« Last Edit: September 24, 2015, 07:46:55 AM by dennis100 » Logged
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« Reply #26 on: February 16, 2015, 07:28:35 AM »

Model Number 103
Event Date 10/22/2013
Event Type Death
Patient Outcome Death
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.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3667938
« Last Edit: September 24, 2015, 07:47:41 AM by dennis100 » Logged
dennis100
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« Reply #27 on: September 24, 2015, 07:48:53 AM »

Model
« Last Edit: November 22, 2017, 03:21:15 AM by dennis100 » Logged
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« Reply #28 on: September 24, 2015, 07:49:55 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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« Reply #29 on: September 24, 2015, 07:50:40 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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