MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTUA?; Cardiac Resynchronization Therapy Pacemaker

Model Number	V273
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this cardiac resynchronization therapy pacemaker (crt-p) was explanted due to a product performance issue.This device was successfully replaced with another model.No additional adverse patient effects were reported outside the revision procedure.This product has not been returned.
Additional Manufacturer Narrative
The local area sales representative was contacted for additional information.At this time, no further information is available.Should additional information become available this report will be updated.

• Brand Name: INTUA?
• Common Device Name: 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 ; EI
• Manufacturer Contact: mark mischke ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(612)875-7234
• MDR Report Key: 23780842
• Report Number: 2124215-2025-90433
• Device Sequence Number: 10079824
• Product Code: NKE
• UDI-Device Identifier: 00802526536670
• UDI-Public: (01)00802526536670(17)160820
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: P030005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Notification,Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2026

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 Expiration Date: 08/20/2016
• Device Model Number: V273
• Device Catalogue Number: V273
• Device Lot Number: 101297
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/05/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2025
• Supplement Date Received by Manufacturer: 09/21/2026
• Initial Report FDA Received Date: 12/11/2025
• Supplement Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/28/2014
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-2016-2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 71 YR
• Patient Sex: Male