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

Model Number G447

Device Problems Failure to Convert Rhythm (1540); Inaccurate Synchronization (1609)

Patient Problem Ventricular Fibrillation (2130)

Event Date 11/24/2023

Event Type  Injury  

Event Description

It was reported that electrogram (egm) review of two ventricular episodes was requested for this cardiac resynchronization therapy defibrillator (crt-d) system.Upon review, the first episode contained ventricular tachycardia (vt) that anti-tachycardia pacing (atp) degraded into ventricular fibrillation (vf), and was later converted with a delivered shock.The second episode began as organized vt that then degraded.A shock was delivered that made the rhythm more organized, but did not convert.The patient received 5 shocks, and the fifth shock converted the rhythm.Therapy was not exhausted.This crt-d remains in service.No additional 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: 18261109
• MDR Text Key: 329641861
• Report Number: 2124215-2023-68577
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/04/2023

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: 04/08/2021
• Device Model Number: G447
• Device Catalogue Number: G447
• Device Lot Number: 213641
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/28/2023
• Initial Date FDA Received: 12/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2019
• 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): Life Threatening
• Patient Age: 58 YR
• Patient Sex: Female