Model Number CDHFA500Q |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Fever (1858); Unspecified Infection (1930); Pocket Erosion (2013)
|
Event Date 02/20/2023 |
Event Type
Injury
|
Event Description
|
Related manufacturer reference number: 2017865-2023-13495.It was reported that a patient presented with infection noted on the patient's system, resulting in fever.A culture was used to confirm the infection.Surgical intervention was taken to explant the system on (b)(6) 2023.The patient was stable throughout.
|
|
Manufacturer Narrative
|
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.
|
|
Event Description
|
New information received notes that pocket erosion was noted.Additionally, no allegation was reported that the infection was caused by the implanted products.
|
|
Manufacturer Narrative
|
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.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.
|
|
Search Alerts/Recalls
|