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

Model Number	6250VC
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Codes	Bradycardia (1751); Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Hypoxia (1918); Cardiac Tamponade (2226); Pericardial Effusion (3271); Syncope/Fainting (4411)
Date of Event	07/22/2024
Type of Reportable Event	Death
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that during the implant procedure, the right ventricular (rv) lead required multiple attempts to be placed and multiple stylets were used.After the rv lead was placed it was determined, after multiple attempts, that the coronary sinus could not be cannulated.The right atrial (ra) lead was inserted through the existing sheath and implanted without difficulty.After the ra lead was implanted, it was observed that the patient was unresponsive, hypotensive and hypoxic requiring bag mask ventilations.The rv and ra leads were removed and the pocket was sutured.Cardiopulmonary resuscitation (cpr) was initiated and emergency medical services (ems) were called.A bedside echocardiogram (echo) was performed and fluid was observed in the pericardial space.The patient experienced bradycardia, cardiac arrest, cardiac tamponade and pericardial effusion.The patient was transferred to a local hospital, where they were pronounced deceased.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was further confirmed in follow up that the cause of death was not related to any lead performance or patient history of disease or patient condition.

• Brand Name: ATTAIN COMMAND
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: gerard torenvliet ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 7635269277
• MDR Report Key: 19816770
• Report Number: 9612164-2024-03378
• Device Sequence Number: 21003506
• Product Code: DQY
• UDI-Device Identifier: 00763000160357
• UDI-Public: 00763000160357
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K123153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/08/2025
• Device Model Number: 6250VC
• Device Catalogue Number: 6250VC
• Device Lot Number: 0012141713
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2024
• Supplement Date Received by Manufacturer: 09/03/2024
• Initial Report FDA Received Date: 07/24/2024
• Supplement Report FDA Received Date: 09/17/2024
• Date Device Manufactured: 02/08/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 85 YR
• Patient Sex: Male