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U.S. Department of Health and Human Services

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

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MEDTRONIC ARCTIC FRONT ADVANCE AND ACHIEVE; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING Back to Search Results
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).
 
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Brand Name
ARCTIC FRONT ADVANCE AND ACHIEVE
Type of Device
CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
Manufacturer (Section D)
MEDTRONIC
MDR Report Key17519116
MDR Text Key321060292
Report NumberMW5126064
Device Sequence Number1
Product Code DRF
Combination Product (y/n)N
Number of Events Reported1
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 Received08/12/2023
Patient Sequence Number1
Treatment
OAE
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