Model Number PM2272 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Fever (1858); Unspecified Infection (1930); Swelling (2091); Discomfort (2330)
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Event Date 08/28/2020 |
Event Type
Injury
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Manufacturer Narrative
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The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
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Event Description
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It was reported that a patient presented in hospital with fever and chills associated with (b)(6).Patient had been on antibiotics.Pocket site was minimally red, with mild discomfort and swollen.The system was extracted and being treated further with antibiotics.The patient tolerated the procedure well.Related manufacturer reference number: 2017865-2020-13268.Related manufacturer reference number: 2017865-2020-13269.
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Manufacturer Narrative
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Additional: d10.The reported field event of infection was not confirmed in the laboratory.The device was tested on the bench and no anomalies were found.
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Search Alerts/Recalls
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