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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC. ATTAIN SELECT II CATHETER, PERCUTANEOUS

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MEDTRONIC, INC. ATTAIN SELECT II CATHETER, PERCUTANEOUS Back to Search Results
Model Number 6248V-130
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Syncope (1610); Death (1802); Diarrhea (1811); Fever (1858); Low Blood Pressure/ Hypotension (1914); Perforation (2001); Ventricular Tachycardia (2132); Weakness (2145); Cardiac Tamponade (2226); Vascular Dissection (3160); Pericardial Effusion (3271)
Event Date 03/02/2020
Event Type  Death  
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
Event Description

It was reported that the patient experienced hypotension, pericardial effusion, and cardiac tamponade. During implant of the left ventricular (lv) lead, the lead was successfully positioned into an acceptable venous branch (only viable one available) but dislodged twice from the branch. During a final attempt at sub-selecting the target vein with a sub-selector catheter, cardiac tamponade was diagnosed. It was also reported that a coronary sinus dissection and perforation had occurred. Medication was administered, and a pericardiocentesis was performed. The lv lead was not implanted, and lv port was capped. The patient was hospitalized for approximately one week, and was recovering well. The ra lead, rv lead and cardiac resynchronization therapy device remain in use. No further patient complications have been reported as a result of this event. The patient is a participant in a clinical study.

 
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Brand NameATTAIN SELECT II
Type of DeviceCATHETER, PERCUTANEOUS
Manufacturer (Section D)
MEDTRONIC, INC.
8200 coral sea street ne
mounds view MN 55112
Manufacturer (Section G)
MEDTRONIC, INC.
8200 coral sea street ne
mounds view MN 55112
Manufacturer Contact
paula bixby
8200 coral sea st ne
mounds view, MN 55112
7635055378
MDR Report Key9881009
MDR Text Key185933190
Report Number2182208-2020-00583
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeCA
PMA/PMN NumberK123153
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/15/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/25/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number6248V-130
Device Catalogue Number6248V-130
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/09/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 03/25/2020 Patient Sequence Number: 1
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