MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INCEPTA? ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)

Model Number	E160
Medical Device Problem Codes	Inappropriate/Inadequate Shock/Stimulation (1574); Communication or Transmission Problem (2896)
Health Effect - Clinical Code	Shock from Patient Lead(s) (3162)
Date of Event	03/12/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This product is being evaluated in our post market quality assurance laboratory.This report will be updated when evaluation is complete.
Event or Problem Description
It was reported that technical services (ts) received notification of a failed remote transmission of data due to this implantable cardioverter defibrillator (icd) exhibited low battery.Additional information was received that the patient with the icd visited the hospital due to inappropriate shock delivery.The device was interrogated and found to be in end of life (eol).Subsequently a device replacement procedure was performed.This icd was explanted due to normal battery depletion (nbd) and replaced with a new device successfully.No additional adverse patient effects were reported.This icd was returned to facility and is awaiting analysis.

• Brand Name: INCEPTA? ICD
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)
• 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: 24837726
• Report Number: 2124215-2026-19486
• Device Sequence Number: 10430121
• Product Code: LWP
• UDI-Device Identifier: 00802526480751
• UDI-Public: (01)00802526480751(17)150829
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/09/2026

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: 08/29/2015
• Device Model Number: E160
• Device Catalogue Number: E160
• Device Lot Number: 107051
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2026
• Initial Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/05/2013
• 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; Other; Hospitalization
• Patient Age: 45 YR
• Patient Sex: Female