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

Model Number	E162
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	11/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this icd and the right ventricular (rv) lead exhibited a high out of range shock impedance measurement, greater than 200 ohms.Technical services (ts) discussed replacing this icd and the rv lead.This icd remains in service.No adverse patient effects were reported.
Additional Manufacturer Narrative
If pertinent information is provided in the future, a supplemental report will be submitted.
Event or Problem Description
It was reported that this icd and the right ventricular (rv) lead exhibited a high out of range shock impedance measurement, greater than 200 ohms.Technical services (ts) discussed replacing this icd and the rv lead.This icd remains in service.No adverse patient effects were reported.
Additional Manufacturer Narrative
This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.The associated investigation determined that there was no conclusive evidence that the observed out-of-range impedance measurements were due to a product performance issue or an inadequate lead-to-device connection.However, intermittent, out-of-range shock lead impedance measurements with no conclusive evidence of a performance issue or an inadequate lead-to-device connection are likely the result of the low-energy test signal utilized for daily automatic or in-clinic commanded shock lead impedance testing.A software update was released in 2015 to further improve consistency of the impedance test results and provide the clinician with additional diagnostic tools, including programmable shock lead impedance alert limits.
Event or Problem Description
It was reported that this icd and the right ventricular (rv) lead exhibited a high out of range shock impedance measurement, greater than 200 ohms.Technical services (ts) discussed replacing this icd and the rv lead.This icd remains in service.No adverse patient effects were reported.Additional information was received.This icd and the rv lead recorded code 1005, indicative of an open circuit condition detected during shock delivery.It was noted the code was recorded while the patient was on the treadmill.The patient was previously lost to follow up, and the device was at battery capacity depleted (bcd) at the time of interrogation.As a result, the shock episode couldn't be reviewed due to bcd.The device was implanted for approximately 13 years and has met expected longevity.The field representative programmed therapy off and discussed replacing the device.At this time, this icd remains in service.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Additional information added to b5.B1, b2, f10, h1, and h6 updated.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: 23688534
• Report Number: 2124215-2025-88006
• Device Sequence Number: 21228543
• Product Code: LWP
• UDI-Device Identifier: 00802526480775
• UDI-Public: (01)00802526480775(17)140510
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: P960040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/22/2026

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: 05/10/2014
• Device Model Number: E162
• Device Catalogue Number: E162
• Device Lot Number: 102466
• 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: 11/03/2025
• Supplement Date Received by Manufacturer: 02/09/2026; 06/10/2026
• Initial Report FDA Received Date: 12/01/2025
• Supplement Report FDA Received Date: 02/11/2026; 06/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2012
• 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: Required Intervention
• Patient Age: 40 YR
• Patient Sex: Male