Model Number CD3369-40Q |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Wound Dehiscence (1154); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
|
Event Date 09/15/2020 |
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 presented for a follow-up in clinic.Upon visual inspection, it was noted that the patient was experiencing wound dehiscence and had developed an infection unrelated to the implantable cardioverter defibrillator - icd system.The icd system was explanted and the patient was in stable condition afterwards.
|
|
Manufacturer Narrative
|
Analysis was normal.No anomalies were found.
|
|
Search Alerts/Recalls
|