MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RESONATE X4 CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D

Model Number G447

Device Problems Pacing Problem (1439); Under-Sensing (1661)

Patient Problems Dyspnea (1816); Insufficient Information (4580)

Event Date 01/12/2024

Event Type  malfunction  

Event Description

It was reported that electrogram (egm) review was requested for this cardiac resynchronization therapy defibrillator (crt-d) due to mode switching concerns.Additionally, the patient was experiencing shortness of breath and difficulty lying flat.Upon review, the patient was in atrial flutter with biventricular (biv) pacing.It was determined that the device was mode switching appropriately, however turning biv pacing revealed that the patient's intrinsic rhythm was driving the rate.Furthermore, there was intermittent atrial undersensing due to blanking associated with biv pacing.This crt-d remains in service.No adverse patient effects were reported.

Manufacturer Narrative

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

• Brand Name: RESONATE X4 CRT-D
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 18611062
• MDR Text Key: 334545582
• Report Number: 2124215-2024-05087
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526589539
• UDI-Public: 00802526589539
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/12/2024
• Device Model Number: G447
• Device Catalogue Number: G447
• Device Lot Number: 281209
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Sex: Male