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Model Number 102 |
Device Problem
Low impedance (2285)
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Patient Problem
Death (1802)
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Event Date 12/07/2012 |
Event Type
Death
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Event Description
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The article "long-term seizure and psychosocial outcomes of vagus nerve stimulation for intractable epilepsy" mentioned that 15 of the vns patients implanted at a certain hospital between 1997 and 2013 that the researchers attempted to contact were found to be deceased.This report will house one of 5 deaths of the known deceased patients that fit the criteria.The patient died on (b)(6) 2012 due to unknown reasons.Programming history suggested low impedance, but there were no patient adverse events to suggest that the death was related to the low impedance in any way.The relationship of the death to vns is unknown.Attempts for further information have been unsuccessful to date.The mfr.Report numbers of the five deaths of known deceased patients are: 1644487-2015-06606, 1644487-2015-06607, 1644487-2015-06608, 1644487-2015-06609, 1644487-2015-06610.
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Event Description
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The patient died from pneumonia.There was no indication that the pneumonia was related to vns in any way.The device was buried with the patient, so no analysis could be performed.
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Manufacturer Narrative
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Evaluation codes; corrected data: the previously submitted mdr inadvertently omitted the new conclusion code per receipt of information relating to cause of death.
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Event Description
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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 unspecified infantile cerebral palsy, which was contributed by unspecified septicemia, congestive heart failure, unspecified pneumonia, unspecified coma, other and unspecified convulsions, foreign body in respiratory tract (part unspecified), and inhalation and ingestion of other objects causing obstruction of respiratory tract.There is no allegation or other information indicating that the death is related to vns.
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Search Alerts/Recalls
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