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

Model Number G447

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

Patient Problems Cardiac Arrest (1762); Ventricular Fibrillation (2130); Electric Shock (2554)

Event Date 04/11/2023

Event Type  Injury  

Event Description

It was reported that this patient with this cardiac resynchronization therapy defibrillator (crt-d) experienced ventricular fibrillation (vf) after anti-tachycardia pacing (atp) therapy was delivered.Then the shock therapy was delivered.However, the shock therapy was unable to covert the vf.Which led to the patient experiencing cardiac arrest.Subsequently, the physician opted to deliver an external shock.An x-ray was performed and the lead was found to be in the same position as the initial implant.It was noted that the patient has an underlying condition, which is being controlled through medication.At this time, the patient is hospitalized and no additional adverse patient effects were reported.The product remains in service.

• 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: 16950929
• MDR Text Key: 315438816
• Report Number: 2124215-2023-24776
• 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: 05/17/2023

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 Expiration Date: 06/14/2021
• Device Model Number: G447
• Device Catalogue Number: G447
• Device Lot Number: 218106
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/02/2023
• Initial Date FDA Received: 05/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2019
• 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): Required Intervention; Hospitalization; Life Threatening
• Patient Age: 71 YR
• Patient Sex: Female