Model Number 3286 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Abdominal Pain (1685)
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Event Type
Injury
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Manufacturer Narrative
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In the event the device is returned to the manufacturer, the reported event cannot be analyzed via laboratory testing.The manufacturer 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.The manufacturer defers to the patient's physician regarding medical history.
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Event Description
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Device 2 of 2, reference mfr.Report#: 1627487-2018-01445.It was reported the patient's scs system was explanted due to the patient experiencing abdominal pain since being implanted.
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Manufacturer Narrative
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Corrected data: patient's weight was inadvertently omitted from the initial report.
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Event Description
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Device 2 of 2, reference mfr.Report#: 1627487-2018-01445.
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Search Alerts/Recalls
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