Model Number 3186 |
Device Problem
Insufficient Information (3190)
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Patient Problems
Hematoma (1884); Coma (2417); Post Operative Wound Infection (2446)
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Event Date 05/12/2017 |
Event Type
Injury
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Manufacturer Narrative
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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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Device 1 of 4.Reference mfr report#1627487-2017-03085.Reference mfr report#1627487-2017-03086.Reference mfr report#1627487-2017-03087.The patient received two extensions with the same lot number.It was reported during permanent implant ((b)(6)) a hematoma was observed at the lead and extension site.Reportedly, the patient was unresponsive after the procedure.Due to infection concern, the scs system was explanted on (b)(6) 2017.Follow-up identified the patient will continue evaluation to confirm the issue.
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Event Description
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Device 1 of 4.Reference mfr report#1627487-2017-03085, reference mfr report#1627487-2017-03086, reference mfr report#1627487-2017-03087.Follow-up identified the patient recently expired due to an unrelated issue.The date of death is unknown.
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Search Alerts/Recalls
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