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

Model Number	E160
Medical Device Problem Codes	High impedance (1291); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) system recorded a code 1005, indicative of high out of range shock impedance measurements, measuring greater than 125 ohms.Technical services (ts) recommended programming options or lead replacement.No adverse patient effects were reported.This icd remains in service.
Additional Manufacturer Narrative
This product investigation is still in progress.This report will be updated when product investigation is complete.If pertinent information is provided in the future, a supplemental report will be submitted.
Additional Manufacturer Narrative
This report is being submitted as additional information was received that this device was explanted and replaced.This product investigation is still in progress.This report will be updated when product investigation is complete.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) system recorded a code 1005, indicative of high out of range shock impedance measurements, measuring greater than 125 ohms.Technical services (ts) recommended programming options or lead replacement.No adverse patient effects were reported.This icd remains in service.Additional information was received that this icd was explanted and replaced.No additional adverse patient effects were reported.This icd has not returned for analysis.
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) system recorded a code 1005, indicative of high out of range shock impedance measurements, measuring greater than 125 ohms.Technical services (ts) recommended programming options or lead replacement.No adverse patient effects were reported.This icd remains in service.Additional information was received that this icd was explanted and replaced.No additional adverse patient effects were reported.This icd has not returned for analysis.
Additional Manufacturer Narrative
This device was not returned for analysis, as it was discarded by the facility; therefore, a technical analysis could not be performed.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 device displays error message 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, boston scientific has assigned an investigation conclusion code of cause not established.This report is being submitted as additional information was received that this device was explanted and replaced.This product investigation is still in progress.This report will be updated when product investigation is complete.If pertinent information is provided in the future, a supplemental report will be submitted.

• 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: 24744573
• Report Number: 2124215-2026-17608
• Device Sequence Number: 18328939
• Product Code: LWP
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: 2026
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/03/2026

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: 08/27/2015
• Device Model Number: E160
• Device Catalogue Number: E160
• Device Lot Number: 106965
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2026
• Supplement Date Received by Manufacturer: 03/27/2026; 06/02/2026
• Initial Report FDA Received Date: 03/31/2026
• Supplement Report FDA Received Date: 04/06/2026; 06/03/2026
• Date Device Manufactured: 08/30/2013
• 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: 88 YR
• Patient Sex: Female