MAUDE Adverse Event Report: MEDTRONIC ARCTIC FRONT ADVANCE AND ACHIEVE; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Device Problem Insufficient Information (3190)

Patient Problems Stroke/CVA (1770); High Blood Pressure/ Hypertension (1908)

Event Date 09/25/2019

Event Type  Injury  

Event Description

It was reported that after an afib cryo case, a stroke occurred post procedure.The patient was complaining of left arm and leg weakness.The neurologist believed that the issue was caused by the patient having high blood pressure and cholesterol.A ct scan was performed, and it came out negative.Also, an mri was ordered but the results are not known.The patient was reported to be in stable condition.Additional information provided stated that the soundstar catheter was not introduced to the left side at any point during procedure.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: ARCTIC FRONT ADVANCE AND ACHIEVE
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 17519116
• MDR Text Key: 321060292
• Report Number: MW5126064
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1
• Treatment: OAE