Model Number 3716 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Death (1802)
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Event Date 01/03/2015 |
Event Type
Death
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Event Description
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Device 1 of 2.Reference mfr.Report#: 1627487-2015-05358.It was reported the patient passed away.The cause of death is unknown.Further device information is unknown pertaining to the patient's lead(s).
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Manufacturer Narrative
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(b)(4).Sjm has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.Sjm defers to the patient's physician regarding medical history.
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Manufacturer Narrative
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: there is no complaint against the returned product and no alleged device failure to meet specification.Therefore no analysis was performed.Sjm has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.Sjm defers to the patient's physician regarding medical history.
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Event Description
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Device 1 of 2.Reference mfr.Report#: 1627487-2015-05358.
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Search Alerts/Recalls
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