MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTUA; CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER

Model Number	V273
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Codes	Dizziness (2194); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this implantable pacemaker was explanted due to non-specific product performance issue.A new device was successfully implanted.No additional adverse patient effects were reported.
Event or Problem Description
It was reported that this implantable pacemaker was explanted due to non-specific product performance issue.A new device was successfully implanted.No additional adverse patient effects were reported.Subsequently, additional information was received indicating that the patient went to the emergency room (er) since the patient was feeling lightheaded and the physician replaced the pacemaker since it stopped working.

• 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; 4100 hamline avenue north; saint paul MN 55112 5798
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 20782121
• Report Number: 2124215-2024-74514
• Device Sequence Number: 12013014
• Product Code: NKE
• UDI-Device Identifier: 00802526536670
• UDI-Public: 00802526536670
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2025

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: 02/17/2017
• Device Model Number: V273
• Device Catalogue Number: V273
• Device Lot Number: 118570
• 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: 10/31/2024
• Supplement Date Received by Manufacturer: 08/18/2025
• Initial Report FDA Received Date: 11/26/2024
• Supplement Report FDA Received Date: 09/08/2025
• Date Device Manufactured: 02/17/2015
• 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: 75 YR
• Patient Sex: Female