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 Bacterial Infection (1735); Unspecified Infection (1930); Pleural Effusion (2010); Sepsis (2067); Heart Failure/Congestive Heart Failure (4446); Swelling/ Edema (4577)

Event Date 02/25/2022

Event Type  Death  

Event Description

It was reported the patient was admitted to the hospital following a motor vehicle accident.At that time it was identified that the patient was in congestive heart failure exacerbation with shortness of breath, bilateral leg edema, elevated brain naturide peptide, and a small left pleural effusion.The patient was diagnosed with methicillin-sensitive staphylococcus aureus bacteremia endocarditis, sepsis and treated with antibiotics.A transesophageal echocardiogram noted an ejection fraction of 15%, as well as small mobile structures attached to the aortic valve and the right atrial (ra) lead.During the hospitalization the patient had episodes of ventricular tachycardia (vt)/ ventricular fibrillation (vf).A right heart cath showed decompensated hemodynamics despite treatment with inotropes.An intra-aortic balloon pump (iabp) was placed for support and an ablation performed.Post ablation, the iabp was removed and the patient continued on inotrope infusion.The patient later requested to be a ¿do not resuscitate¿.At that time, the cardiac resynchronization therapy defibrillator (crt-d) was deactivated, the inotropes and antibiotics discontinued and the patient was transferred to hospice where they died four days later.The cause of death was provided as chronic congestive heart failure.The patient was a participant in a clinical study.

Manufacturer Narrative

Concomitant medical products: 511212 x 2 leads, implanted (b)(6) 2019.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: 14194466
• MDR Text Key: 289981772
• Report Number: 3004209178-2022-05209
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2020
• Device Model Number: DTMA1D4
• Device Catalogue Number: DTMA1D4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/30/2022
• Date Device Manufactured: 09/05/2018
• 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: 5076-52 LEAD, 6935M62 LEAD
• Patient Outcome(s): Death
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 75 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White