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

Model Number DTPA2QQ

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

Patient Problems Pulmonary Embolism (1498); Dyspnea (1816); Hemorrhage/Bleeding (1888); Intracranial Hemorrhage (1891); Muscle Weakness (1967); Pain (1994); Pleural Effusion (2010); Pulmonary Edema (2020); Tachycardia (2095); Stenosis (2263); Obstruction/Occlusion (2422); Respiratory Failure (2484); Syncope/Fainting (4411); Hemorrhagic Stroke (4417); Heart Failure/Congestive Heart Failure (4446)

Event Date 09/03/2022

Event Type  Death  

Event Description

It was reported that two days after a new cardiac resynchronization therapy defibrillator (crt-d) was implanted for a generator change procedure, the patient was hospitalized for a thromboembolic cerebral vascular accident (cva) at the middle cerebral artery and a thrombectomy was performed.It was noted that prior to the generator change procedure, the patient's anticoagulant medication had been held and were resumed the night before the procedure.About 6 days later the patient was transferred to an acute rehabilitation facility but returned by emergency medical services to the emergency room (er) later that day for worsening right-sided weakness and respiratory distress.The patient also experienced pain in their right foot and syncope.It was also noted that the crt-d had delivered appropriate therapy for monomorphic ventricular tachycardia (vt).It was then noted that an antiarrhythmic meditation had not been given to the patient because it had been incorrectly documented as "declined" in the patient's chart.Antiarrhythmic meditation was provided to the patient.A computerized tomography (ct) scan was performed and revealed an iliac occlusion and a renal artery occlusion.The ct scan also revealed extensive bilateral pulmonary edema, severe cardiomegaly, bilateral pleural effusions, a left frontal intraparenchymal hemorrhage with surrounding edema, and a small amount of subarachnoid hemorrhage within left frontal sulci.Emergent intervention of the right lower leg was performed with vascular thrombectomy.An ultrasound revealed complete occlusions in several femoral arteries consistent with severe stenosis.The patient also developed a pulmonary embolism with congestive heart failure and the patient experienced acute hypoxemic respiratory failure that required bilevel positive airway pressure (bipap).Approximately four days after the return to the emergency room, the patient's family chose to proceed with comfort care and the crt-d defibrillation therapy was programmed off.The patient passed away the next day.The cause of death was listed as renal artery occlusion.The patient is a participant in a clinical study.

Manufacturer Narrative

Concomitant medical products: 429888 lead, implanted: (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.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¿ XT 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: 15941278
• MDR Text Key: 305076081
• Report Number: 9614453-2022-03814
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00763000178093
• UDI-Public: 00763000178093
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/14/2023
• Device Model Number: DTPA2QQ
• Device Catalogue Number: DTPA2QQ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/23/2022
• Date Device Manufactured: 06/23/2022
• 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: 6947M55 LEAD, 5076-45 LEAD,
• Patient Outcome(s): Death
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Race: White