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

Model Number	E160
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this device recorded a code 1003, which states that the voltage is too low for projected remaining capacity.A request was made to have data from this device analyzed.Data analysis showed that the voltage was valid and the battery voltage recently began dropping in an irregular fashion.Device replacement was recommended.This icd was explanted, replaced with different model and was returned for analysis.No additional adverse patient effects were reported.

• 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 ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 24546565
• Report Number: 2124215-2026-12871
• Device Sequence Number: 18512948
• Product Code: LWP
• UDI-Device Identifier: 00802526480751
• UDI-Public: (01)00802526480751(17)161009
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P960040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/09/2026

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: 10/09/2016
• Device Model Number: E160
• Device Catalogue Number: E160
• Device Lot Number: 112320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2026
• Initial Report FDA Received Date: 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/14/2014
• 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: Required Intervention; Hospitalization
• Patient Age: 59 YR
• Patient Sex: Male