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

Model Number	E160
Medical Device Problem Codes	Signal Artifact/Noise (1036); Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Code	Shock from Patient Lead(s) (3162)
Date of Event	08/26/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) delivered two inappropriate electric shocks.Technical services (ts) reviewed device data and suspected the shocks were delivered due to oversensing of electromagnetic interference (emi) noise.The noise was unable to be reproduced with isometrics, and the patient didn't know what they were doing at the time of the episode.Device therapy was not exhausted.It was noted right ventricular (rv) lead measurements were all stable and within normal limits.This icd remains in service.No adverse patient effects were reported.
Additional Manufacturer Narrative
This product remains in service.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.A risk review was completed and confirmed that the event of oversensing 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.Review of labeling determined that the complaint situation was listed in the manual.There was no indication in the complaint that the product was not used in accordance to labeling.The manual was unlikely to be the cause of the reported complaint; translation, wording, or graphics does not require further review.Based on a thorough review of the reported complaint, the conclusion code known inherent risk of device was assigned, because it can be concluded that expected or well-understood factors most probably contributed to the event.
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) delivered two inappropriate electric shocks.Technical services (ts) reviewed device data and suspected the shocks were delivered due to oversensing of electromagnetic interference (emi) noise.The noise was unable to be reproduced with isometrics, and the patient didn't know what they were doing at the time of the episode.Device therapy was not exhausted.It was noted right ventricular (rv) lead measurements were all stable and within normal limits.This icd remains in service.No 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: 24487173
• Report Number: 2124215-2026-11432
• Device Sequence Number: 21501786
• Product Code: LWP
• UDI-Device Identifier: 00802526480751
• UDI-Public: (01)00802526480751(17)160527
• 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: 2014
• 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): 05/20/2026

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: 05/27/2016
• Device Model Number: E160
• Device Catalogue Number: E160
• Device Lot Number: 110333
• 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: 02/19/2026
• Supplement Date Received by Manufacturer: 05/18/2026
• Initial Report FDA Received Date: 03/02/2026
• Supplement Report FDA Received Date: 05/20/2026
• Date Device Manufactured: 06/03/2014
• 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
• Patient Age: 71 YR
• Patient Sex: Male