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

Model Number	E162
Medical Device Problem Codes	Signal Artifact/Noise (1036); Failure to Capture (1081); Low impedance (2285)
Health Effect - Clinical Codes	Unspecified Infection (1930); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This investigation will be updated should pertinent information become available in the future.
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) system exhibited noise that resulted in false atrial tachy response (atr) episodes on the right atrial (ra) channel.It was also noted that there was intermittent or total loss of capture and a singular drop in impedance measurements, which remained in range.This icd system remains in service and no adverse patient effects were reported.
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) system exhibited noise that resulted in false atrial tachy response (atr) episodes on the right atrial (ra) channel.It was also noted that there was intermittent or total loss of capture and a singular drop in impedance measurements, which remained in range.This icd system remains in service and no adverse patient effects were reported.Additional information was received that this icd was explanted and replaced due to normal battery depletion and an infection.No additional adverse patient effects were reported.This icd has not returned for analysis.
Additional Manufacturer Narrative
This report is being submitted as additional information was received that this device was explanted and replaced.This investigation will be updated should pertinent information become available in the future.

• 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: 23244040
• Report Number: 2124215-2025-71278
• Device Sequence Number: 21443065
• Product Code: LWP
• UDI-Device Identifier: 00802526480775
• UDI-Public: (01)00802526480775(17)150709
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2026

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: 07/09/2015
• Device Model Number: E162
• Device Catalogue Number: E162
• Device Lot Number: 107472
• 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: 09/17/2025
• Supplement Date Received by Manufacturer: 02/23/2026
• Initial Report FDA Received Date: 10/08/2025
• Supplement Report FDA Received Date: 03/23/2026
• Date Device Manufactured: 07/12/2013
• 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; Hospitalization
• Patient Age: 41 YR
• Patient Sex: Male