MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INCEPTA? ICD; Implantable cardioverter defibrillator (ICD)

Model Number	E162
Medical Device Problem Codes	High impedance (1291); Off-Label Use (1494)
Health Effect - Clinical Code	Syncope/Fainting (4411)
Date of Event	11/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented to the emergency department following a syncopal event.Device interrogation indicated that atrial pacing impedance on the atrial channel was greater than 2500 ohms.The atrial lead is manufactured by a third-party (non-boston scientific) manufacturer.No arrhythmic episodes were recorded within the device's programmed data collection period that would correlate with the reported syncopal event.Review of the presenting electrogram (egm) demonstrated that the device was operating as programmed.It was also noted that the patient had been lost to follow-up for approximately eight years.The reported clinical observations were documented.The system remains in service, and 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: mark mischke ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(612)875-7234
• MDR Report Key: 25550664
• Report Number: 2124215-2026-32691
• Device Sequence Number: 10731546
• Product Code: LWP
• UDI-Device Identifier: 00802526480775
• UDI-Public: (01)00802526480775(17)141114
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: P960040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2026

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: 11/14/2014
• Device Model Number: E162
• Device Catalogue Number: E162
• Device Lot Number: 104772
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/18/2026
• Supplement Report FDA Received Date: 09/04/2026
• Date Device Manufactured: 11/16/2012
• 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: 32 YR
• Patient Sex: Male