MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RESONATE X4 CRT-D; Implantable cardiac resynchronization therapy defibrillator

Model Number	G447
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bradycardia (1751); Low Blood Pressure/ Hypotension (1914)
Date of Event	08/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) experienced a low heart rate of 48 beats per minute and low blood pressure readings.Subsequently, a nurse rechecked and recent blood pressure was 104 over 55 millimeters of mercury and heart rate was 60 to 66 beats per minute.The boston scientific technical services consultant referred the patient to the device-following physician.As of this time, this crt-d remains in service.No adverse patient effects were reported.

• Brand Name: RESONATE X4 CRT-D
• Common Device Name: Implantable cardiac resynchronization therapy defibrillator
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline ave n; saint paul MA 55112
• Manufacturer (Section G): Boston Scientific Corporation; cashel road; clonmel, E91 T 862; EI E91 T862
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(651)582-6168
• MDR Report Key: 50548042
• Report Number: 2124215-2026-45965
• Device Sequence Number: 18804260
• Product Code: NIK
• UDI-Device Identifier: 00802526589539
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P010012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Consumer
• Type of Report: Initial
• Report Date (Section B): 09/01/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 12/02/2022
• Device Model Number: G447
• Device Catalogue Number: G447
• Device Lot Number: 250772
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2026
• Initial Report FDA Received Date: 09/01/2026
• Date Device Manufactured: 12/10/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Sex: Male