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

Model Number	E163
Medical Device Problem Code	Delayed Charge Time (2586)
Health Effect - Clinical Code	Ventricular Fibrillation (2130)
Date of Event	12/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) exhibited a charge time greater than 15 seconds during a ventricular fibrillation episode.Despite this, anti tachycardia pacing and a shock were delivered, converting the rhythm successfully.The charge time during capacitor reformation was within acceptable limits.Technical services was consulted and indicated it was physician discretion to consider device replacement before reaching elective replacement indicator based on charge time from the presented episode.No additional adverse patient effects were reported.This device remains in service.
Additional Manufacturer Narrative
This product investigation is still in progress.This report will be updated when product investigation is complete.
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) exhibited a charge time greater than 15 seconds during a ventricular fibrillation episode.Despite this, anti tachycardia pacing and a shock were delivered, converting the rhythm successfully.The charge time during capacitor reformation was within acceptable limits.Technical services was consulted and indicated it was physician discretion to consider device replacement before reaching elective replacement indicator based on charge time from the presented episode.No additional adverse patient effects were reported.This device remains in service.Additional information was received.This icd was explanted and successfully replaced.No additional adverse patient effects were reported.This device has not been returned for analysis.

• 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: 23934143
• Report Number: 2124215-2025-93914
• Device Sequence Number: 21239406
• Product Code: LWP
• UDI-Device Identifier: 00802526480782
• UDI-Public: (01)00802526480782(17)160704
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2026

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: 07/04/2016
• Device Model Number: E163
• Device Catalogue Number: E163
• Device Lot Number: 108652
• 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: 12/16/2025
• Supplement Date Received by Manufacturer: 04/14/2026
• Initial Report FDA Received Date: 12/31/2025
• Supplement Report FDA Received Date: 04/29/2026
• Date Device Manufactured: 07/11/2014
• 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: Other; Required Intervention; Hospitalization
• Patient Age: 72 YR
• Patient Sex: Male