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

Model Number	N160
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) was explanted and replaced due to a non specific product performance anomaly.No additional adverse patient effects were reported.This device has not been returned.
Additional Manufacturer Narrative
Additional information was received indicating that this device was explanted and replaced due to normal battery depletion rather than a product performance anomaly.Therefore, this event no longer meets reportability nor complaint criteria.
Event or Problem Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) was explanted and replaced due to a non-specific product performance anomaly.No additional adverse patient effects were reported.This device has not been returned.Additional information was received indicating that this device was explanted and replaced due to normal battery depletion.

• Brand Name: INCEPTA CRT-D
• Common Device Name: CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D)
• 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: 21465324
• Report Number: 2124215-2025-11670
• Device Sequence Number: 8749783
• Product Code: LWP
• UDI-Device Identifier: 00802526480997
• UDI-Public: 00802526480997
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P010012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2025
• 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): 03/05/2025

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: 10/18/2014
• Device Model Number: N160
• Device Catalogue Number: N160
• Device Lot Number: 877376
• 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: 02/10/2025
• Supplement Date Received by Manufacturer: 03/03/2025
• Initial Report FDA Received Date: 02/25/2025
• Supplement Report FDA Received Date: 03/05/2025
• Date Device Manufactured: 10/23/2012
• 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: 85 YR
• Patient Sex: Female