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

Model Number	E161
Medical Device Problem Codes	High impedance (1291); Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If pertinent information is provided in the future, a supplemental report will be submitted.
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) delivered three inappropriate shocks.Technical services (ts) suspected the shocks were due to atrial fibrillation (af) with rapid ventricular response (rvr).However, this was unable to be confirmed as the device reached elective replacement indicator (eri) and battery capacity depleted (bcd).The device has implanted for 10+ years and expectations for longevity have been met.Also, there was a slight gradual rise of shock impedance from 55 to 65 ohms.This implantable cardioverter defibrillator (icd) was explanted and replaced.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
This product was explanted and was not returned.As such, physical analysis has not been conducted in our laboratory.As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.A review of the device history record (dhr) was performed.The review of the dhr identified that there were no process related non-conformances, scrap, or rework performed during the production that could explain the event.The reviews ensure each device meets specification prior to release for use.There is no indication the device manufacturing process contributed to the reported complaint.Labeling review information confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.A risk review was completed and confirmed that the event of inappropriate shock was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Based on a thorough review of the reported complaint, the conclusion code unable to exclude device problem was assigned, because the reported observations were traced to the device, but a specific cause could not be determined.
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) delivered three inappropriate shocks.Technical services (ts) suspected the shocks were due to atrial fibrillation (af) with rapid ventricular response (rvr).However, this was unable to be confirmed as the device reached elective replacement indicator (eri) and battery capacity depleted (bcd).The device has implanted for 10+ years and expectations for longevity have been met.Also, there was a slight gradual rise of shock impedance from 55 to 65 ohms.This implantable cardioverter defibrillator (icd) was explanted and replaced.No additional adverse patient effects were reported.

• 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: 23380020
• Report Number: 2124215-2025-76483
• Device Sequence Number: 18358779
• Product Code: LWP
• UDI-Device Identifier: 00802526480768
• UDI-Public: (01)00802526480768(17)140922
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P960040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2026

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: 09/22/2014
• Device Model Number: E161
• Device Catalogue Number: E161
• Device Lot Number: 103065
• 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: 10/02/2025
• Supplement Date Received by Manufacturer: 02/26/2026
• Initial Report FDA Received Date: 10/24/2025
• Supplement Report FDA Received Date: 03/02/2026
• Date Device Manufactured: 09/25/2012
• 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: 54 YR
• Patient Sex: Male