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

Model Number	E163
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Defibrillation/Stimulation Problem (1573); Low impedance (2285); Delayed Charge Time (2586)
Health Effect - Clinical Codes	Loss of consciousness (2418); Syncope/Fainting (4411)
Date of Event	04/16/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) was found to not have delivered a shock for ventricular fibrillation (vf).The patient was found unresponsive in their car.Upon, interrogation fault codes 1004 and 1007 were found.The patient was hospitalized and subsequently this icd system was explanted and replaced.This icd has been received for investigation.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: 25164853
• Report Number: 2124215-2026-25964
• Device Sequence Number: 21488771
• Product Code: LWP
• UDI-Device Identifier: 00802526480782
• UDI-Public: (01)00802526480782(17)160407
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P960040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/13/2026

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: 04/07/2016
• Device Model Number: E163
• Device Catalogue Number: E163
• Device Lot Number: 107735
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2026
• Initial Report FDA Received Date: 05/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/14/2014
• 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: 70 YR
• Patient Sex: Female