MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. CLARIA MRI CRT-D SURESCAN; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

Model Number DTMA1D4

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

Patient Problems Arrhythmia (1721); Aspiration/Inhalation (1725); Fever (1858); Hypoxia (1918); Unspecified Infection (1930); Pleural Effusion (2010); Respiratory Tract Infection (2420); Respiratory Failure (2484); Cognitive Changes (2551); Heart Failure/Congestive Heart Failure (4446); Drug Resistant Bacterial Infection (4553); Peripheral Edema (4578)

Event Date 08/25/2022

Event Type  Death  

Event Description

It was reported that the patient was admitted to the hospital for evaluation of irregular heart rate, congestive heart failure exacerbation, and altered mental status.The patient was noted to have bilateral lower extremity pitting edema.Intravenous diuretics and antibiotics were administered.The patient tested positive for human metapneumovirus and blood cultures were positive for methicill in-resistant staphylococcus aureus.A chest x-ray showed left and right-sided pleural effusions with bibasal atelactasis and a transesophageal echocardiogram (tee) revealed lead vegetation in the right atrium.The patient developed high grade fever one week post-admission.The patient was also noted to have undergone cystoscopy and foley placement.The patient underwent extraction of the cardiac resynchronization therapy defibrillator (crt-d) system one week later and a leadless pacemaker was implanted.The rapid response team was called for hypoxic/hypercapnic respiratory failure five days later.The patient was intubated and transferred to the intensive care unit (icu) where they expired five days later.The patient was thought to have aspirated.The cause of death reported was acute on chronic systolic and diastolic heart failure.The patient is a participant in a clinical study.No further information was reported.

Manufacturer Narrative

Concomitant medical products: mc1vr01us ipg, implanted: (b)(6) 2022.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: CLARIA MRI CRT-D SURESCAN
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 15923146
• MDR Text Key: 304871835
• Report Number: 3004209178-2022-15986
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00643169720657
• UDI-Public: 00643169720657
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/14/2021
• Device Model Number: DTMA1D4
• Device Catalogue Number: DTMA1D4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2022
• Date Device Manufactured: 09/26/2019
• 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: 383069 LEAD (X2), 6935M62 LEAD
• Patient Outcome(s): Death
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Weight: 78 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White