MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INCEPTA? CRT-D; CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR

Model Number	N161
Medical Device Problem Codes	Defective Device (2588); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) went off five times.Boston scientific technical services (ts) referred patient to the clinic.This device remains in service.No adverse patient effects were reported.
Event or Problem Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) went off five times.Boston scientific technical services (ts) referred patient to the clinic.This device remains in service.No adverse patient effects were reported.Additional information received which indicating that this device was explanted.A new device was then implanted.No additional adverse patient effects were reported.

• Brand Name: INCEPTA? CRT-D
• Common Device Name: CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR
• 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: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 21689263
• Report Number: 2124215-2025-18352
• Device Sequence Number: 13026436
• Product Code: LWP
• UDI-Device Identifier: 00802526481000
• UDI-Public: (01)00802526481000(17)161009(21)502594
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P010012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2026

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: 10/09/2016
• Device Model Number: N161
• Device Catalogue Number: N161
• Device Lot Number: 502594
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2025
• Supplement Date Received by Manufacturer: 02/04/2026
• Initial Report FDA Received Date: 03/25/2025
• Supplement Report FDA Received Date: 02/16/2026
• Date Device Manufactured: 10/16/2014
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 73 YR
• Patient Sex: Male