MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VISIONIST? CRT-P; Implantable Cardiac Resynchronization Therapy Pacemaker

Model Number	U225
Medical Device Problem Codes	Pacing Problem (1439); Under-Sensing (1661)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this cardiac resynchronization therapy pacemaker (crt-p) exhibited undersensing and a decrease in biventricular pacing.Technical services (ts) was consulted and confirmed the undersensing was through the non-boston scientific atrial lead.Ts informed the health care professional that this allows intrinsic beats to occur and prevents the biventricular pacing.Ts reviewed measurements and recommended programming atrial sensitivity to a nominal value.No adverse patient effects were reported.This crt-p remains 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: VISIONIST? CRT-P
• Common Device Name: Implantable Cardiac Resynchronization Therapy Pacemaker
• 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: 50754468
• Report Number: 2124215-2026-48893
• Device Sequence Number: 9414839
• Product Code: NKE
• UDI-Device Identifier: 00802526559426
• UDI-Public: (01)00802526559426(17)250308
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P030005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/14/2026

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: 03/08/2025
• Device Model Number: U225
• Device Catalogue Number: U225
• Device Lot Number: 725476
• 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: 09/01/2026
• Initial Report FDA Received Date: 09/14/2026
• Date Device Manufactured: 05/31/2023
• 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: 69 YR
• Patient Sex: Male