Model Number CD3357-40C |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Erosion (1750); Unspecified Infection (1930)
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Event Date 03/04/2022 |
Event Type
Injury
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Manufacturer Narrative
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A device history record (dhr) review was performed and all required manufacturing processes and inspections steps were confirmed to be completed per the requirements.The device met specifications prior to leaving abbott manufacturing facilities.Review of the sterilization records confirmed normal sterilization cycles for the products.The cause of infection could not be determined.
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Event Description
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Related manufacturer reference number: 2017865-2022-09617 , 2017865-2022-09618 , 2017865-2022-09635.It was reported that the patient presented to the hospital with septic shock-like symptoms due to an infection.The infection was identified by a culture were methicillin-susceptible staphylococcus aureus(mssa) bacteria was found.The device was eroding from the skin and the leads had vegetation.The entire system was explanted.The patient condition was stable post-procedure.
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Manufacturer Narrative
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A device history record (dhr) review was performed and review of the sterilization records confirmed normal sterilization cycles for the products.The device met specifications prior to leaving abbott manufacturing facilities.The product was returned and visual inspection was normal.The cause of infection could not be traced to the device.
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Search Alerts/Recalls
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