MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INCEPTA? ICD; Implantable Cardioverter Defibrillator

Model Number	E160
Medical Device Problem Codes	Pacing Problem (1439); Defibrillation/Stimulation Problem (1573); Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Codes	Tachycardia (2095); Ventricular Fibrillation (2130)
Date of Event	08/04/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This product investigation is still in progress.This report will be updated when product investigation is complete.If pertinent information is provided in the future, a supplemental report will be submitted.
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) delivered inappropriate shocks and anti-tachycardia pacing (atp) that induced ventricular tachycardia.Additionally, inappropriate continued to be delivered resulting in the rhythm accelerating from ventricular tachycardia to ventricular fibrillation.Technical services (ts) was consulted and confirmed four bursts of atp and two shocks; all being deemed inappropriate.Ts additionally confirmed that the third burst of atp accelerating the rhythm as previously mentioned.Ts recommended increasing the ventricular tachycardia rate cutoff, rate controlling the patient, or turning on additional features for the ventricular tachycardia zone.No additional adverse patient effects were reported.This icd remains in service.

• Brand Name: INCEPTA? ICD
• Common Device Name: Implantable Cardioverter Defibrillator
• 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: 50254250
• Report Number: 2124215-2026-43683
• Device Sequence Number: 10193708
• Product Code: LWP
• UDI-Device Identifier: 00802526480751
• UDI-Public: (01)00802526480751(17)161111
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P960040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2026

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: 11/11/2016
• Device Model Number: E160
• Device Catalogue Number: E160
• Device Lot Number: 112818
• 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: 08/05/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/14/2026
• Supplement Report FDA Received Date: 08/20/2026
• Date Device Manufactured: 11/17/2014
• 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: Life Threatening
• Patient Age: 71 YR
• Patient Sex: Female