Model Number 1458Q/86 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Death (1802); Endocarditis (1834); Unspecified Infection (1930); Staphylococcus Aureus (2058)
|
Event Date 05/06/2018 |
Event Type
Injury
|
Manufacturer Narrative
|
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.
|
|
Event Description
|
It was reported that the patient was admitted to the hospital due to acute and subacute bacterial endocarditis.The potential cause was methicillin resistant staphylococcus aureus infection (mrsa).The patient was a known mrsa carrier years before implant.The patient was discharged and sent home on 5/25/2018.No further information could be obtained.
|
|
Manufacturer Narrative
|
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.
|
|
Event Description
|
New information received stated that after the implantable cardioverter defibrillator was explanted on (b)(6) 2018, the patient passed away on (b)(6) 2018.
|
|
Manufacturer Narrative
|
Correction: should not contain "death" as an adverse event and should not have a death date.Please disregard the event of death in the previous report.The patient had an implantable cardioverter defibrillator system removal on (b)(6) 2018 and was terminated type of reportable event should be serious injury.(b)(4).
|
|
Search Alerts/Recalls
|