MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RESONATE X4 CRT-D; CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR

Model Number G447

Device Problems Pacing Problem (1439); Inappropriate/Inadequate Shock/Stimulation (1574); Inaccurate Synchronization (1609)

Patient Problems Ventricular Fibrillation (2130); Electric Shock (2554)

Event Date 06/30/2023

Event Type  Injury  

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) was suspected of accelerating rhythm intro ventricular fibrillation after anti-tachycardia pacing (atp) and several shocks.The patient was externally converted on the way to the emergency room.Technical services (ts) was consulted about possible reprogramming options to discriminate atrial fibrillation (af) with rapid ventricular response.Defibrillation threshold (dft) test was not successful.This crt-d remains in service.No additional adverse patient effects were reported.

Manufacturer Narrative

The returned device was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.Visual examination of the device header and case noted no anomalies.Dimensional analysis of the header was completed.Each port measured as expected.The device was then exposed to simulated heart load conditions, and the defibrillation, pacing, and sensing functions were tested.Testing measurements were within normal limits excepting shock range which was below specification.Analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) was suspected of accelerating rhythm intro ventricular fibrillation after anti-tachycardia pacing (atp) and several shocks.The patient was externally converted on the way to the emergency room.Technical services (ts) was consulted about possible reprogramming options to discriminate atrial fibrillation (af) with rapid ventricular response.Defibrillation threshold (dft) test was not successful.This crt-d remains in service.No additional adverse patient effects were reported.

• Brand Name: RESONATE X4 CRT-D
• Type of Device: CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR
• 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: 17308877
• MDR Text Key: 318917253
• Report Number: 2124215-2023-36699
• 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,Followup
• Report Date: 03/04/2024

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: 02/08/2024
• Device Model Number: G447
• Device Catalogue Number: G447
• Device Lot Number: 277445
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 07/05/2023
• Initial Date FDA Received: 07/12/2023
• Supplement Dates Manufacturer Received: 02/29/2024
• Supplement Dates FDA Received: 03/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/16/2022
• 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
• Patient Outcome(s): Life Threatening; Other
• Patient Age: 35 YR
• Patient Sex: Male