MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VISIONIST? X4 CRT-P; cardiac resynchronization therapy pacemaker (CRT-P)

Model Number	U228
Medical Device Problem Codes	Signal Artifact/Noise (1036); Over-Sensing (1438); Pacing Problem (1439)
Health Effect - Clinical Codes	Syncope/Fainting (4411); Asystole (4442)
Date of Event	05/16/2025
Type of Reportable Event	Serious Injury

• Brand Name: VISIONIST? X4 CRT-P
• Common Device Name: cardiac resynchronization therapy pacemaker (CRT-P)
• 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: 50658147
• Report Number: 2124215-2026-47684
• Device Sequence Number: 15820653
• Product Code: NKE
• UDI-Device Identifier: 00802526559471
• UDI-Public: (01)00802526559471(17)261223
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: P030005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: U228
• Device Catalogue Number: U228
• Device Lot Number: 807489
• 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: 08/24/2026
• Supplement Date Received by Manufacturer: 09/07/2026
• Initial Report FDA Received Date: 09/07/2026
• Supplement Report FDA Received Date: 09/14/2026
• Date Device Manufactured: 01/20/2025
• 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: Other; Hospitalization
• Patient Age: 86 YR
• Patient Sex: Female