Model Number 3186 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Hemorrhage/Bleeding (1888)
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Event Date 05/09/2018 |
Event Type
Injury
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Manufacturer Narrative
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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 2.Reference mfr.Report#: 3006705815-2018-01312.It was reported the patient underwent a permanent, scs implant procedure.During the procedure, the patient began to bleed excessively.As a result, the procedure was abandoned.The patient might be sent for labs to determine why his blood wasn't clotting regularly.
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Event Description
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Device 1 of 2: reference mfr.Report#: 3006705815-2018-01312.Follow-up revealed the patient is doing well.
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Manufacturer Narrative
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Corrected data: date received by manufacturer (upon further review, it was determined the awareness date listed on the previous follow-up report was incorrect.The correct date was (b)(6) 2018.).
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Event Description
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Device 1 of 2 :reference mfr.Report#: 3006705815-2018-01312.
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Search Alerts/Recalls
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