MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INCEPTA CRT-D; Implantable Pulse Generator, Pacemaker (Non-Crt)

Model Number	N160
Medical Device Problem Codes	Pacing Problem (1439); Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Code	Shock from Patient Lead(s) (3162)
Date of Event	02/22/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this implantable pacemaker delivered inappropriate anti-tachycardia pacing (atp) and electric shock for what appeared to be atrial fibrillation (af) with rapid ventricular response (rvr).Technical services (ts) suggested reprogramming options.Physician was discussing af ablation.Device remains in service.No additional adverse patient effects were reported.

• 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 E91 T 862; EI E91 T862
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(651)582-6168
• MDR Report Key: 20380055
• Report Number: 2124215-2024-62335
• Device Sequence Number: 7878227
• Product Code: LWP
• UDI-Device Identifier: 00802526480997
• UDI-Public: (01)00802526480997(17)160418
• 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: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/11/2026

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: 04/18/2016
• Device Model Number: N160
• Device Catalogue Number: N160
• Device Lot Number: 955295
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/21/2025
• 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: 09/12/2024
• Supplement Date Received by Manufacturer: 07/29/2026; 07/31/2026; 08/10/2026
• Initial Report FDA Received Date: 10/06/2024
• Supplement Report FDA Received Date: 07/31/2026; 07/31/2026; 08/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/29/2014
• 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: Other
• Patient Age: 60 YR
• Patient Sex: Female