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

Model Number DTPB2D1

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

Patient Problems Low Blood Pressure/ Hypotension (1914); Unspecified Infection (1930); Nausea (1970); Sepsis (2067); Dizziness (2194); Skin Infection (4544)

Event Date 09/10/2023

Event Type  Injury  

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 reported that the cardiac resynchronization therapy defibrillator (crt-d) and left ventricular (lv) lead were explanted due to a systemic bacteremia infection.No further patient complications have been reported as a result of this event.

Event Description

It was reported that the cardiac resynchronization therapy defibrillator (crt-d) and left ventricular (lv) lead were explanted due to a systemic bacteremia infection.No further patient complications have been reported as a result of this event.(b)(6) 2024 it was further reported that the patient had presented to the hospital due to experiencing nausea, dizziness, hypotension and fever.It was noted the patient had sepsis (several times) and also had a soft tissue skin infection from right and left foot skin ulcers.It was noted an antibacterial absorbable envelope was in use at the time of the reported infection.Medications were administered as a result of the event.The patient is a participant in a clinical study.

Manufacturer Narrative

Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: COBALT¿ HF 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: 17868847
• MDR Text Key: 324895379
• Report Number: 9614453-2023-03522
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00763000178222
• UDI-Public: 00763000178222
• 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: 05/03/2024

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: 08/14/2023
• Device Model Number: DTPB2D1
• Device Catalogue Number: DTPB2D1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/13/2023
• Initial Date FDA Received: 10/04/2023
• Supplement Dates Manufacturer Received: 04/06/2024
• Supplement Dates FDA Received: 05/03/2024
• Date Device Manufactured: 02/16/2022
• 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: 419588 LEAD,; CMRM6133 TYRX
• Patient Outcome(s): Life Threatening; Required Intervention; Hospitalization
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Weight: 141 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White