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

Model Number	G447
Medical Device Problem Codes	Signal Artifact/Noise (1036); Over-Sensing (1438); Pacing Problem (1439); Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the medical doctor (md) called technical services (ts) questioning the right ventricular (rv) sensing and pacing for this cardiac resynchronization therapy defibrillator (crt-d).Ts reviewed the data and noted the presenting electrogram (egm) showed rv pace followed by atrial sensing and that sometimes there was likely fusion for two beats.Ts also noted there was a pacemaker mediated tachycardia (pmt) episode in late august and noise on the rv rate sense channel that was not sensed.Ts also discussed there was one beat of right atrial (ra) oversensing and an episode with a premature ventricular contraction (pvc).Ts stated there were no anomalies with the rv sensing that they noticed.Information from the field was received and noted the patient would continue to be monitored.No adverse patient effects were reported.This crt-d remains in service.
Additional Manufacturer Narrative
This product investigation is still in progress.This report will be updated when product investigation is complete.

• Brand Name: RESONATE? X4 CRT-D
• Common Device Name: cardiac resynchronization therapy defibrillator (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 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: 50808332
• Report Number: 2124215-2026-49750
• Device Sequence Number: 21478111
• Product Code: NIK
• UDI-Device Identifier: 00802526589539
• UDI-Public: (01)00802526589539(17)220304
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P010012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 03/04/2022
• Device Model Number: G447
• Device Catalogue Number: G447
• Device Lot Number: 235786
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2026
• Initial Report FDA Received Date: 09/17/2026
• Date Device Manufactured: 03/18/2020
• 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: 76 YR
• Patient Sex: Male