MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INCEPTA CRT-D; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

Model Number	N161
Medical Device Problem Codes	Signal Artifact/Noise (1036); Premature Discharge of Battery (1057); Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330); Shock from Patient Lead(s) (3162)
Date of Event	08/29/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product has been received for analysis.This report will be updated upon completion of analysis.
Event or Problem Description
It was reported that this previously implanted cardiac resynchronization therapy defibrillator (crt-d) system had a fractured right ventricular (rv) lead which exhibited noise with oversensing and delivered inappropriate tachy therapy.Additionally, this lead issue resulted in increased battery power consumption.It was noted that this lead issue occurred back in 2020, when it was difficult to find an available hospital room in order for the patient to undergo a lead revision.It was believed that the patient had five leads in his body at one point.Some of those leads had been revised, and a defibrillation lead had been implanted for a device with three leads.As a result of these issues, the patient reported severe discomfort/pain/distress.This crt-d was explanted and replaced with a cardiac resynchronization therapy pacemaker (crt-p) during a therapy downgrade, and additional information from the field representative at that time mentioned that the patient no longer needed a defibrillator.No additional adverse patient effects were reported.This crt-d was returned for analysis.

• Brand Name: INCEPTA CRT-D
• Common Device Name: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
• 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: 22150657
• Report Number: 2124215-2025-36990
• Device Sequence Number: 8347750
• Product Code: LWP
• UDI-Device Identifier: 00802526481000
• UDI-Public: (01)00802526481000(17)160905
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: P010012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 06/05/2025

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: 09/05/2016
• Device Model Number: N161
• Device Catalogue Number: N161
• Device Lot Number: 502318
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2025
• Initial Report FDA Received Date: 06/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/12/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male