Model Number 3189 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hematoma (1884); Weakness (2145); Numbness (2415)
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Event Date 12/06/2017 |
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 2.Reference mfr.Report: 1627487-2017-08736.It was reported ((b)(6)) the patient underwent an scs trial procedure on (b)(6) 2017.The patient experienced numbness in the pelvic and abdominal region shortly after the procedure.Stimulation was not turned on at this time.A ct scan revealed a possible hematoma.The patient reportedly developed weakness and a heavy sensation in the left leg later in the day.As such, the leads were explanted.The patient was hospitalized and has since reported improved symptoms, however pelvic numbness persists.Details on device 2 are unknown.
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Manufacturer Narrative
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The reported event cannot be analyzed via laboratory testing.
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Event Description
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Device 1 of 2, reference mfr.Report: 1627487-2017-08736.Additional information received identified the pelvic numbness has improved.
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Search Alerts/Recalls
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