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

Model Number	E163
Medical Device Problem Code	Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Code	Shock from Patient Lead(s) (3162)
Date of Event	07/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the healthcare professional (hcp) contacted technical services (ts) regarding a consult transmission from an implantable cardioverter defibrillator (icd).The device detected a rhythm in the ventricular fibrillation (vf) zone and delivered quick convert anti-tachycardia pacing (atp), which briefly terminated the arrhythmia.However, the rhythm spontaneously recurred, prompting the device to initiate charging.Before shock delivery, the rhythm self-terminated, but the shock was committed and delivered while the patient was in normal sinus rhythm.The device accurately sensed the rhythm throughout the episode.The inappropriate shock was attributed to device timing and programming logic.This device remains in service.No additional adverse patient effects were reported.

• Brand Name: INCEPTA? ICD
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (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: 22588616
• Report Number: 2124215-2025-49876
• Device Sequence Number: 9052360
• Product Code: LWP
• UDI-Device Identifier: 00802526480782
• UDI-Public: (01)00802526480782(17)160624
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/24/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 06/24/2016
• Device Model Number: E163
• Device Catalogue Number: E163
• Device Lot Number: 108553
• 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: 07/03/2025
• Initial Report FDA Received Date: 07/24/2025
• Date Device Manufactured: 06/30/2014
• 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
• Patient Age: 31 YR
• Patient Sex: Female