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

Model Number	E162
Medical Device Problem Codes	Pacing Problem (1439); Delayed Charge Time (2586); Battery Problem (2885)
Health Effect - Clinical Code	Syncope/Fainting (4411)
Date of Event	02/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) had reached a battery status indicator of explant.The battery status a 6 days previous indicated 9 months remaining to explant.The explant indicator was found to be due to extended charge times.Data analysis confirmed that the power consumption is normal and charge times increased normally.There were multiple charges that occurred on 02 february and then an interrogation on 06 february.A normal replacement interval is expected.In addition, it was noted that the patient experienced a syncope episode related to multiple episodes of ventricular arrythmia and two shocks were appropriately delivered.Device appears to be functioning as programmed.Currently, evidence suggests that the device remains in service.No adverse patient effects were reported.
Additional Manufacturer Narrative
This product remains in service and has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.It was confirmed that this device met manufacturing specifications prior to distribution and there was no indication that the device manufacturing process contributed to the reported complaint.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.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.A risk review was completed and confirmed that the event of delayed charge time 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.
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) had reached a battery status indicator of explant.The battery status a 6 days previous indicated 9 months remaining to explant.The explant indicator was found to be due to extended charge times.Data analysis confirmed that the power consumption is normal and charge times increased normally.There were multiple charges that occurred on 02 february and then an interrogation on 06 february.A normal replacement interval is expected.In addition, it was noted that the patient experienced a syncope episode related to multiple episodes of ventricular arrythmia and two shocks were appropriately delivered.Device appears to be functioning as programmed.Currently, evidence suggests that the device 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: 24345687
• Report Number: 2124215-2026-08566
• Device Sequence Number: 10004918
• Product Code: LWP
• UDI-Device Identifier: 00802526480775
• UDI-Public: (01)00802526480775(17)160703
• 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: 2015
• 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): 04/27/2026

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: 07/03/2016
• Device Model Number: E162
• Device Catalogue Number: E162
• Device Lot Number: 112627
• 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: 02/03/2026
• Supplement Date Received by Manufacturer: 04/27/2026
• Initial Report FDA Received Date: 02/16/2026
• Supplement Report FDA Received Date: 04/27/2026
• Date Device Manufactured: 07/09/2014
• 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: 48 YR
• Patient Sex: Male