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

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.

• Brand Name: ATTAIN COMMAND
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business; park west; galway ; IE
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business; park west; galway ; IE
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 10413152
• MDR Text Key: 203105288
• Report Number: 9612164-2020-03003
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K123153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• 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 Received: 08/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 6250VIC
• Device Catalogue Number: 6250VIC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/11/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Life Threatening; Required Intervention
• Patient Age: 56 YR
• Patient Weight: 72