Model Number CDHFA500Q |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Unspecified Infection (1930)
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Event Type
Injury
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Manufacturer Narrative
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Further information was requested, but not received.
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Event Description
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Related manufacturer reference number: 2017865-2023-11351 related manufacturer reference number: 2017865-2023-11352 related manufacturer reference number: 2017865-2023-11354 it was reported that patient presented with infection noted on the patient's implantable cardioverter defibrillator system.The system was explanted on (b)(6) 2023.No further patient consequences were reported.
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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 and found no malfunctions.Interrogation of the device revealed it was above elective replacement indicator (eri) when received.Based on this information, the device was found to communicate appropriately with a merlin programmer and has not reached the elective replacement indicator (eri).The cause of infection could not be traced to the device.
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Search Alerts/Recalls
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