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

Model Number DTPB2D4

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

Patient Problem Endocarditis (1834)

Event Date 04/05/2022

Event Type  Injury  

Event Description

It was reported that the patient had developed endocarditis with vegetation on the leads.The cardiac resynchronization therapy defibrillator (crt-d) system was explanted and the patient was treated with antibiotics. no further patient complications have been reported as a result of this event.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• 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: 14246962
• MDR Text Key: 290379588
• Report Number: 9614453-2022-01224
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00763000178215
• UDI-Public: 00763000178215
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/28/2022

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: 06/28/2023
• Device Model Number: DTPB2D4
• Device Catalogue Number: DTPB2D4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/05/2022
• Initial Date FDA Received: 04/28/2022
• Date Device Manufactured: 01/11/2022
• 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: 419688 LEAD, 5076-52 LEAD, 6935M62 LEAD
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male