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

Model Number	E162
Medical Device Problem Codes	Signal Artifact/Noise (1036); Over-Sensing (1438); Failure to Read Input Signal (1581); Under-Sensing (1661); Low impedance (2285)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) system exhibited noise oversensing as well as alerts for intrinsic amplitude out of range with under sensing on both the right atrial (ra) lead and right ventricular (rv) lead channels.It was also noted that a decrease in shock impedance measurements from 70 ohms to 49 ohms occurred.Technical services (ts) was consulted, and upon review it was mentioned that the noise could be related to cautery noise during a medical procedure, however further in office evaluation was recommended.No adverse patient effects were reported.This system remains in service.
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) system exhibited noise oversensing as well as alerts for intrinsic amplitude out of range with under sensing on both the right atrial (ra) lead and right ventricular (rv) lead channels.It was also noted that a decrease in shock impedance measurements from 70 ohms to 49 ohms occurred.Technical services (ts) was consulted, and upon review it was mentioned that the noise could be related to cautery noise during a medical procedure, however further in office evaluation was recommended.No adverse patient effects were reported.This system remains in service.Additional information was received indicating that the cause of the observations was a cardioversion procedure.No adverse patient effects were reported.This system remains in service.

• 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: 22906291
• Report Number: 2124215-2025-60277
• Device Sequence Number: 9089234
• Product Code: LWP
• UDI-Device Identifier: 00802526480775
• UDI-Public: (01)00802526480775(17)160814
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P960040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• 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): 09/02/2025

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: 08/14/2016
• Device Model Number: E162
• Device Catalogue Number: E162
• Device Lot Number: 113134
• 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: 08/11/2025
• Supplement Date Received by Manufacturer: 08/27/2025
• Initial Report FDA Received Date: 08/27/2025
• Supplement Report FDA Received Date: 09/02/2025
• Date Device Manufactured: 08/22/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 82 YR
• Patient Sex: Male