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

Model Number DTPA2D1

Device Problem Mechanical Problem (1384)

Patient Problems Dyspnea (1816); Device Overstimulation of Tissue (1991); Dizziness (2194)

Event Date 10/30/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the patient experienced pocket stimulation, shortness of breath and dizziness.It was noted that the right atrial (ra) lead exhibited high and undefined impedance, noise, loss of atrial capture and oversensing.The ra lead was programmed off until a revision could be performed.Follow up revealed the ra lead set screw was not fully engaged in the cardiac resynchronization therapy defibrillator (crt-d).The screw was tightened and the device remains in use.The lead remains in use.No further patient complications have been reported as a result of this event.

• Brand Name: COBALT¿ XT 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: 12867982
• MDR Text Key: 281194985
• Report Number: 9614453-2021-04410
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00763000178147
• UDI-Public: 00763000178147
• 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: 11/24/2021

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/28/2022
• Device Model Number: DTPA2D1
• Device Catalogue Number: DTPA2D1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/30/2021
• Initial Date FDA Received: 11/24/2021
• Date Device Manufactured: 05/10/2021
• 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: 4965-35 LEAD, 694765 LEAD, 407652 LEAD
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 145 KG