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

Model Number DTPA2Q1

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

Patient Problems Chest Pain (1776); Dyspnea (1816); Endocarditis (1834); Fall (1848); Unspecified Infection (1930); Pneumonia (2011); Sepsis (2067)

Event Date 05/15/2023

Event Type  Death  

Event Description

It was reported that the patient is deceased.  the patient presented to the emergency department with complaints of dyspnea with worsening heart failure.  the patient was administered diuretic medication.  additionally, it was reported that the patient had a fall two weeks prior with persistent right chest pain.  the patient also suffered from multiple comorbidities heart failure, diabetes and end stage renal disease.  the patient was admitted and diuresed and continued on dialysis.Diagnostic findings were suggestive of pneumonia and echocardiogram revealed left ventricular ejection fraction is increased to seventy-five percent.  urine culture revealed urinary tract infection and multidrug-resistant klebsiella pneumonia.  despite being, treated with antibiotics the patient continued to have fevers, elevated white blood count and bacteremia.  the patient underwent computed tomography arterial portography (ctap), showing acute gallbladder inflammation and c-tube placement with interventional radiology that was complicated by coffee ground emesis.Transesophageal echocardiography (tee) showed lead associated endocarditits.  it was also reported that during hospitalization an exploratory laparotomy with open gall bladder removal, vac placement with second look, with additional bowel resection was performed.  postoperatively, the patient continued to remain on vasopressors with rising lactate, and worsening sepsis shock.Post dis charge, two weeks later the patient passed away.  the patient is a participant in a clinical study.

Manufacturer Narrative

Continuation of d10: 505da20 mechanical valve; implanted: on (b)(6) 2010; 694765 lead; implanted: on (b)(6) 2008.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.

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.

Event Description

It was further reported the tee revealed an echodensity on the right atrial (ra) lead that was noted to likely represent endocarditis given the patient's history of bacteremia.

• 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: 17438790
• MDR Text Key: 320195800
• Report Number: 9614453-2023-02649
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00763000178109
• UDI-Public: 00763000178109
• 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,Followup
• Report Date: 09/06/2023

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/28/2023
• Device Model Number: DTPA2Q1
• Device Catalogue Number: DTPA2Q1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/01/2023
• Supplement Dates Manufacturer Received: 08/19/2023
• Supplement Dates FDA Received: 09/06/2023
• Date Device Manufactured: 04/08/2022
• 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: 459878 LEAD, 5076-45 LEAD
• Patient Outcome(s): Hospitalization; Death; Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 110 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White