MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INCEPTA ICD; IMPLANTABLE PACEMAKER

Model Number	E161
Medical Device Problem Code	Failure to Convert Rhythm (1540)
Health Effect - Clinical Code	Arrhythmia (1721)
Date of Event	04/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the system with this implantable cardioverter defibrillator (icd) and right ventricular (rv) lead failed to convert arrhythmia at initial implant.Technical services (ts) reviewed the data and noted shock lead impedance (sli) had been stable since 2017.This device was explanted and replaced with a new lead.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Product investigation is currently underway.A supplemental final report will be filed upon investigation completion.

• Brand Name: INCEPTA ICD
• Common Device Name: IMPLANTABLE PACEMAKER
• 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: 24963330
• Report Number: 2124215-2026-21979
• Device Sequence Number: 14690950
• Product Code: LWP
• UDI-Device Identifier: 00802526480768
• UDI-Public: (01)00802526480768(17)140420
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P960040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/23/2026

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: 04/20/2014
• Device Model Number: E161
• Device Catalogue Number: E161
• Device Lot Number: 102396
• 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: 04/01/2026
• Initial Report FDA Received Date: 04/23/2026
• Date Device Manufactured: 04/26/2012
• 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: Hospitalization; Required Intervention
• Patient Age: 52 YR
• Patient Sex: Female