Model Number 102
Event Date 10/01/2006
Event Type Other Patient Outcome Other;
Manufacturer Narrative
Reporter stated ncp system unrelated to death event.
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
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
Model Number 102
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
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
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
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
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
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
Event Date 10/01/2006
Event Type Other Patient Outcome Other;
Manufacturer Narrative
Reporter stated ncp system unrelated to death event.
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
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
Model Number 102
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
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
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
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
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
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