MAUDE Adverse Event Report: MEDTRONIC EUROPE SARL COBALT¿ HF QUAD CRT-D MRI SURESCAN¿; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

Model Number DTPB2Q1

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Arrest (1762); Chest Pain (1776); Hematoma (1884); Asystole (4442); Heart Block (4444)

Event Date 12/10/2023

Event Type  Death  

Manufacturer Narrative

Continuation of d10: 4574 lead implant date: (b)(6) 2017 medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the right ventricular (rv) lead exhibited a small decrease of impedance and a small increase in threshold since implant.  twelve days post implant of the cardiac resynchronization therapy defibrillator (crt-d), rv lead, and left ventricular (lv) lead, the patient was brought into the hospital by ambulance due to chest pain and collapsed upon arrival.The patient was unresponsive and cardiac arrest was confirmed.The patient was ventilated with a bag valve mask.The patient exhibited pulseless electrical activity (pea) and cardiopulmonary resuscitation was performed for two minutes.The patient was administered adrenaline.There was a brief return of spontaneous circulation.The pea remained until shock like movements were observed in the left arm.A magnet was applied to the crt-d and five external shocks were delivered to the patient.The patient was treated with adrenaline and amiodarone after the third shock. left chest wall bruising noted from the onset and the patient's hemoglobin fell by four units during the resuscitation.The hematoma on left chest wall expanded.There was no pericardial effusion or right ventricular dilatation seen on bedside echocardiogram and lung sliding was observed.The rhythm changes to pea followed by asystole.The decision was made to stop resuscitation attempts.The patient was deceased.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: COBALT¿ HF QUAD CRT-D MRI SURESCAN¿
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• Manufacturer (Section D): MEDTRONIC EUROPE SARL; route du molliau 31; case postale; tolochenaz vaud 1131 ; SZ 1131
• Manufacturer (Section G): MEDTRONIC EUROPE SARL; route du molliau 31; case postale; tolochenaz vaud 1131 ; SZ 1131
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 18358646
• MDR Text Key: 330905274
• Report Number: 9614453-2023-04675
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P010031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/28/2024
• Device Model Number: DTPB2Q1
• Device Catalogue Number: DTPB2Q1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/28/2022
• 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
• Treatment: 693565 LEAD, 459888 LEAD.
• Patient Outcome(s): Death