MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VISIONIST? CRT-P; Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

Model Number	U225
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pocket Erosion (2013); Impaired Healing (2378)
Date of Event	03/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this cardiac resynchronization therapy pacemaker (crt-p) experienced impaired healing of pocket site.Reportedly, the site was unable to heal since implant.According to the physician, the patient agrees that the pocket site never really healed.Ultimately, the patient's dog jumped on the chest and ripped the site open.There were no additional adverse patient effects reported.The crt-p was explanted.

• Brand Name: VISIONIST? CRT-P
• Common Device Name: Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (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: 50601112
• Report Number: 2124215-2026-47050
• Device Sequence Number: 10710614
• Product Code: NKE
• UDI-Device Identifier: 00802526559426
• UDI-Public: (01)00802526559426(17)270811
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P030005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/03/2026

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 Model Number: U225
• Device Catalogue Number: U225
• Device Lot Number: 734128
• 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: Not provided
• Initial Report FDA Received Date: 09/04/2026
• Date Device Manufactured: 08/22/2025
• 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
• Patient Age: 67 YR
• Patient Sex: Female