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Model Number 8637-40 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Erythema (1840); Unspecified Infection (1930); Scar Tissue (2060)
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Event Date 04/04/2020 |
Event Type
Injury
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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Information was received from a consumer regarding a patient receiving baclofen (500 mcg/ml at 2 mcg/day) via an implanted pump.On (b)(6) 2020 the patient reported that on b)(6) 2020 she developed redness and a scab over the incision at the pump pocket.She was started on antibiotics; the pump was weaned down to minimum rate; and she was started on oral baclofen.She was unaware if there were any environmental, external, or patient factors that may have led or contributed to the issue and unaware if any diagnostics and/or troubleshooting had been performed.On (b)(6) 2020 the device system was explanted and would not be replaced in the future.The issue was not resolved at the time of the report.The patient status was reported as ¿alive ¿ no injury¿.No further complications were reported/anticipated.
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Search Alerts/Recalls
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