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

Model Number	E163
Medical Device Problem Codes	Over-Sensing (1438); Pacing Problem (1439); Failure to Read Input Signal (1581)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the field representative was contacted by the health care professional (hcp) who reported that the patient with this implantable cardioverter defibrillator (icd) system had received inappropriate anti-tachycardia pacing (atp) burst due to t wave oversensing on the right ventricular (rv) lead.Technical services (ts) was consulted for further review of the stored episode.It was noted that the rv lead is a non-boston scientific lead.Ts reviewed the provided data and confirmed the inappropriate atp.Ts also noted that the patient appeared to have high sinus rates and a decrease in r wave amplitudes.Ts discussed possible findings with the field representative and recommended an in-person visit for further evaluation.Subsequently, the field representative reported that the physician will reprogram the device settings and will continue to monitor at this time.At this time, the icd and rv lead remain in service.No adverse patient effects were reported.
Event or Problem Description
It was reported that the field representative was contacted by the health care professional (hcp) who reported that the patient with this implantable cardioverter defibrillator (icd) system had received inappropriate anti-tachycardia pacing (atp) burst due to t wave oversensing on the right ventricular (rv) lead.Technical services (ts) was consulted for further review of the stored episode.It was noted that the rv lead is a non-boston scientific lead.Ts reviewed the provided data and confirmed the inappropriate atp.Ts also noted that the patient appeared to have high sinus rates and a decrease in r wave amplitudes.Ts discussed possible findings with the field representative and recommended an in person visit for further evaluation.Subsequently, the field representative reported that the physician will reprogram the device settings and will continue to monitor at this time.At this time, the icd and rv lead remain in service.No adverse patient effects were reported.Subsequent additional information was received that reported that during a follow up visit, the icd system was evaluated, and the lead measurements were found to be normal with good sensing measurements.It was noted that the patient had a history of inappropriate therapy caused by t wave oversensing with a previous device system.The clinic attempted to recreate the issue; however, were unable to.Xray images were taken.The images showed the non-boston scientific rv lead in position but with a slight slack.The clinic attempted to recreate the problem but were unsuccessful and cannot confirm if the slack observed on the xray is contributing to the issue.The physician reprogrammed the device settings.At this time, the icd and non-boston scientific rv lead remain in service.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
This report is being submitted to correct the initial reporter first/last name (e1) in section e, initial reporter.
Event or Problem Description
It was reported that the field representative was contacted by the health care professional (hcp) who reported that the patient with this implantable cardioverter defibrillator (icd) system had received inappropriate anti-tachycardia pacing (atp) burst due to t wave oversensing on the right ventricular (rv) lead.Technical services (ts) was consulted for further review of the stored episode.It was noted that the rv lead is a non-boston scientific lead.Ts reviewed the provided data and confirmed the inappropriate atp.Ts also noted that the patient appeared to have high sinus rates and a decrease in r wave amplitudes.Ts discussed possible findings with the field representative and recommended an in person visit for further evaluation.Subsequently, the field representative reported that the physician will reprogram the device settings and will continue to monitor at this time.At this time, the icd and rv lead remain in service.No adverse patient effects were reported.Subsequent additional information was received that reported that during a follow up visit, the icd system was evaluated, and the lead measurements were found to be normal with good sensing measurements.It was noted that the patient had a history of inappropriate therapy caused by t wave oversensing with a previous device system.The clinic attempted to recreate the issue however were unable to.Xray images were taken.The images showed the non-boston scientific rv lead in position but with a slight slack.The clinic attempted to recreate the problem but were unsuccessful and cannot confirm if the slack observed on the xray is contributing to the issue.The physician reprogrammed the device settings.At this time, the icd and non-boston scientific rv lead remain in service.No additional adverse patient effects were reported.

• Brand Name: INCEPTA? ICD
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (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: 22367476
• Report Number: 2124215-2025-43436
• Device Sequence Number: 4436967
• Product Code: LWP
• UDI-Device Identifier: 00802526480782
• UDI-Public: (01)00802526480782(17)161020
• Combination Product (Y/N): N
• Initial Reporter State: ND
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/06/2026

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: 10/20/2016
• Device Model Number: E163
• Device Catalogue Number: E163
• Device Lot Number: 109639
• 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: 06/20/2025
• Supplement Date Received by Manufacturer: 07/02/2025; 02/27/2026
• Initial Report FDA Received Date: 06/30/2025
• Supplement Report FDA Received Date: 07/03/2025; 03/06/2026
• Date Device Manufactured: 10/23/2014
• 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: 43 YR
• Patient Sex: Female