MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RESONATE? HF CRT-D; Implantable Cardiac Resynchronization Therapy Defibrillator

Model Number	G547
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	Asystole (4442)
Date of Event	09/07/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) presented to the emergency room with asystole and transcutaneous pacing for resuscitation.Technical services (ts) was notified that an emergency device replacement occurred to a competitors device.Ts reviewed data and found only four successful left ventricular automatic threshold tests in the previous three months; however, no reason was provided.The device was returned to boston scientific for further analysis.No additional adverse patient effects were reported.This crt-d is no longer in service.
Additional Manufacturer Narrative
This product investigation is still in progress.This report will be updated when product investigation is complete.If pertinent information is provided in the future, a supplemental report will be submitted.

• Brand Name: RESONATE? HF CRT-D
• Common Device Name: Implantable 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 E91 T 862; EI E91 T862
• Manufacturer Contact: mark mischke ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(612)875-7234
• MDR Report Key: 50801950
• Report Number: 2124215-2026-49625
• Device Sequence Number: 13397861
• Product Code: NIK
• UDI-Device Identifier: 00802526589744
• UDI-Public: (01)00802526589744(17)270403
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P010012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/17/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: G547
• Device Catalogue Number: G547
• Device Lot Number: 359968
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/11/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2026
• Initial Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/16/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization; Life Threatening
• Patient Age: 77 YR
• Patient Sex: Male