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

Model Number G447

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

Patient Problems Ventricular Fibrillation (2130); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/07/2023

Event Type  Injury  

Event Description

It was reported that anti-tachycardia pacing (atp) and ventricular shock therapy was delivered to convert an arrhythmia.The arrhythmia was detected in the ventricular tachycardia (vt) zone after which two anti-tachycardia pacing (atp) therapies were delivered, which then accelerated the arrhythmia into the ventricular fibrillation (vf) zone and was successfully converted with a 41 j shock.No adverse patient effects were reported.The device remains implanted.

Manufacturer Narrative

This investigation is complete.Should additional information become available this investigation will be updated.

Event Description

It was reported that anti-tachycardia pacing (atp) and ventricular shock therapy was delivered to convert an arrhythmia.The arrhythmia was detected in the ventricular tachycardia (vt) zone after which two anti-tachycardia pacing (atp) therapies were delivered, which then accelerated the arrhythmia into the ventricular fibrillation (vf) zone and was successfully converted with a 41 j shock.No adverse patient effects were reported.The device remains implanted.

Manufacturer Narrative

This report is being filed to update the patient identifier.

Event Description

It was reported that anti-tachycardia pacing (atp) and ventricular shock therapy was delivered to convert an arrhythmia.The arrhythmia was detected in the ventricular tachycardia (vt) zone after which two anti-tachycardia pacing (atp) therapies were delivered, which then accelerated the arrhythmia into the ventricular fibrillation (vf) zone and was successfully converted with a 41 j shock.No adverse patient effects were reported.The device remains implanted.

• 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: 17690966
• MDR Text Key: 322740327
• Report Number: 2124215-2023-48306
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P010012/S436
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/17/2023

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 Model Number: G447
• Device Catalogue Number: G447
• Device Lot Number: 291252
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/03/2023
• Initial Date FDA Received: 09/06/2023
• Supplement Dates Manufacturer Received: 09/11/2023; 10/12/2023
• Supplement Dates FDA Received: 09/11/2023; 10/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 75 YR