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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC. CATHETER, INTRAVASCULAR, DIAGNOSTIC

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MEDTRONIC, INC. CATHETER, INTRAVASCULAR, DIAGNOSTIC Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problem Foreign Body In Patient (2687)
Event Date 04/16/2022
Event Type  No Answer Provided  
Event Description
Mid 40¿s woman with left vertebral artery dissection and basilar occlusion. Patient presented for cerebral angiography and mechanical thrombectomy. Mri on the following day identified a focal area of susceptibility in the right occipital lobe. Mri confirmed artifact.
 
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Type of DeviceCATHETER, INTRAVASCULAR, DIAGNOSTIC
Manufacturer (Section D)
MEDTRONIC, INC.
710 medtronic pkwy.
minneapolis MN 55432
MDR Report Key14564552
MDR Text Key293102914
Report Number14564552
Device Sequence Number1
Product Code DQO
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 05/16/2022,04/16/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/01/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/16/2022
Event Location Hospital
Date Report to Manufacturer06/01/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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