MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INCEPTA? ICD; Implantable Cardioverter Defibrillator

Model Number	E162
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) recorded a red call doctor due to shock impedance out of range.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 ; +1(651)582-6168
• MDR Report Key: 24729275
• Report Number: 2124215-2026-17221
• Device Sequence Number: 13083078
• Product Code: LWP
• UDI-Device Identifier: 00802526480775
• UDI-Public: (01)00802526480775(17)160429
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P960040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2026

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: 04/29/2016
• Device Model Number: E162
• Device Catalogue Number: E162
• Device Lot Number: 111700
• 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: 03/12/2026
• Supplement Date Received by Manufacturer: 08/05/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 08/07/2026
• Date Device Manufactured: 05/07/2014
• 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: Male