Model Number 3660 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Edema (1820); Inflammation (1932); Pain (1994)
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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.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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The patient has multiple scs systems implanted and this report is related to the scs system implanted on (b)(6) 2016.It was reported that the patient experienced swelling and inflammation at the ipg site.The patient was given prophylactic antibiotics, although the surgeon confirmed that their was no infection.Patient underwent surgical intervention on (b)(6) 2017 to have their ipg pocket cleaned out and revised.
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Event Description
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Follow up revealed that the patients ipg was explanted (reference mfr report 1627487-2017-01965).The patient's pain has been resolved.
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Search Alerts/Recalls
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