Model Number 1192 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Abscess (1690); Unspecified Infection (1930)
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Event Date 12/21/2018 |
Event Type
Injury
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Manufacturer Narrative
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The results/method and conclusion codes along with investigation results will be provided in the final report.
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Event Description
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Related manufacturer numbers: 3006705815-2019-01981; 3006705815-2019-01982; 1627487-2019-06214.It was reported that the patient developed a suture abscess and was hospitalized.As a result, the patient had an incision and drainage procedure at the lead site on (b)(6) 2019 and was prescribed antibiotics.
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Manufacturer Narrative
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Corrected information: infection was added as a patient code, which was not included in the initial report.
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Event Description
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Related manufacturer reference numbers: 3006705815-2019-01981.3006705815-2019-01982.1627487-2019-06214.Additional information was received that patient's infection did not resolve.As a result, surgical intervention was undertaken wherein the system was explanted.
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Event Description
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Related manufacturer reference numbers: 3006705815-2019-01981.3006705815-2019-01982.1627487-2019-06214.
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Search Alerts/Recalls
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