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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC IRELAND ATTAIN COMMAND CATHETER, PERCUTANEOUS

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MEDTRONIC IRELAND ATTAIN COMMAND CATHETER, PERCUTANEOUS Back to Search Results
Model Number 6250VIC
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Cardiac Tamponade (2226); Pericardial Effusion (3271)
Event Date 08/11/2020
Event Type  Death  
Manufacturer Narrative

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

 
Event Description

It was reported that during the implant procedure, the patient experienced tamponade and pericardial effusion while attempting to im plant the left ventricular (lv) lead. It was uncertain what caused the injury, because at some point the patient woke up and contracted their muscles violently raising their arms and legs. Almost all of the material on the sterile field fell out. The physician was at the time purging the sheath on the operating table. It was believed that the sudden movement could have caused an impact of the sheath in place into the sinus causing the tamponade. The implant was abandoned. A pericardial puncture was performed under ultrasound and drainage completed. Adrenaline was administered. The patient later died. The cause of death was determined to be tamponade on cardiogenic arrest.

 
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Brand NameATTAIN COMMAND
Type of DeviceCATHETER, PERCUTANEOUS
Manufacturer (Section D)
MEDTRONIC IRELAND
parkmore business
park west
galway
Manufacturer (Section G)
MEDTRONIC IRELAND
parkmore business
park west
galway
Manufacturer Contact
paula bixby
8200 coral sea st ne
mounds view, MN 55112
7635055378
MDR Report Key10413152
MDR Text Key203105288
Report Number9612164-2020-03003
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeFR
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
Report Date 08/17/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/17/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number6250VIC
Device Catalogue Number6250VIC
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 Received08/11/2020
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: 08/17/2020 Patient Sequence Number: 1
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