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); Inaccurate Synchronization (1609); Under-Sensing (1661)

Patient Problem Arrhythmia (1721)

Event Date 05/21/2023

Event Type  Injury  

Event Description

It was reported that there was a stored ventricular episode on this cardiac resynchronization therapy defibrillator (crt-d) where the right ventricular (rv) lead pacing was on the t-wave.Technical services (ts) analyzed device episode data and determined that this was due to the patient's premature ventricular contractions (pvc) causing under-sensing of the rv beat which would fall into the programmed blanking period after the atrial pacing was delivered.It was noted that this rv pacing possibly induced the ventricular tachycardia (vt) arrhythmia.The rhythm terminated on its own without therapy delivery.Ts discussed device reprogramming and optimization as troubleshooting.Health care professional (hcp) stated that these changes will be implemented at the patient's next scheduled follow-up visit.No additional adverse patient effects were reported.Currently, this crt-d remains in service.

• 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: 17086125
• MDR Text Key: 316783143
• Report Number: 2124215-2023-29390
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526589539
• UDI-Public: 00802526589539
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010012/S436
• 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: 06/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/07/2023
• Device Model Number: G447
• Device Catalogue Number: G447
• Device Lot Number: 258188
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2021
• 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
• Patient Outcome(s): Other
• Patient Age: 66 YR
• Patient Sex: Male