Model Number 3186 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Abscess (1690)
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Event Date 11/07/2017 |
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 1 of 4.Reference mfr.Report#: 3006705815-2017-07190.Reference mfr.Report#: 1627487-2017-07857.Reference mfr.Report#: 1627487-2017-07858.It was reported an abscess was found near the patient's lead site.No cultures have been taken and no antibiotics have been administered.The patient will undergo surgical intervention to address the issue.
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Event Description
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Device 1 of 4.Reference mfr.Report#: 3006705815-2017-07190, reference mfr.Report#: 1627487-2017-07857, reference mfr.Report#: 1627487-2017-07858.Follow-up revealed the patient's scs system was explanted.
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Event Description
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Device 1 of 4: reference mfr.Report#: 3006705815-2017-07190; reference mfr.Report#: 1627487-2017-07857; reference mfr.Report#: 1627487-2017-07858.Follow-up revealed the patient's issue remains ongoing.In turn, the doctor re-packed the patient's incision(s) and prescribed bactrim ds to the patient.
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Search Alerts/Recalls
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