Model Number 1194 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Post Operative Wound Infection (2446); Fluid Discharge (2686)
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Event Type
Injury
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Event Description
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Device 5 of 5.Reference mfr.Report: 3006705815-2018-03342, reference mfr.Report: 1627487-2018-13112, reference mfr.Report: 3006705815-2018-03343, reference mfr.Report: 3006705815-2018-03344.It was reported the patient experienced drainage at the ipg and lead incision sites on (b)(6) 2018.The patient also reported feeling feverish and sick since (b)(6) 2018.Cultures were taken and the patient was prescribed antibiotics.
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Event Description
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Device 5 of 5.Reference mfr.Report: 3006705815-2018-03342, 1627487-2018-13112, 3006705815-2018-03343, 3006705815-2018-03344.Additional information provided estimated explant date of (b)(6) 2018.
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Event Description
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Device 5 of 5.Reference mfr.Report: 3006705815-2018-03342, 1627487-2018-13112, 3006705815-2018-03343, 3006705815-2018-03344, follow-up information provided the patient underwent scs system explant (exact date unknown) due to infection.The patient does not have therapy.
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Event Description
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Device 5 of 5.Reference mfr.Report: 3006705815-2018-03342, 1627487-2018-13112, 3006705815-2018-03343, 3006705815-2018-03344.Additional information provided the infection has resolved.
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Search Alerts/Recalls
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