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

Model Number	E161
Medical Device Problem Codes	Signal Artifact/Noise (1036); High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) exhibited a high out of range shock lead impedance (sli) measurement of greater than 200 ohms.The sli returned to normal at the following daily measurement.Technical services (ts) recommended continuous monitoring.This device remains in service.No adverse patient effects were reported.
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) exhibited a high out of range shock lead impedance (sli) measurement of greater than 200 ohms.The sli returned to normal at the following daily measurement.Technical services (ts) recommended continuous monitoring.This device 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 implantable cardioverter defibrillator (icd) exhibited a high out of range shock lead impedance (sli) measurement of greater than 200 ohms.The sli returned to normal at the following daily measurement.Technical services (ts) recommended continuous monitoring.This device remains in service.No adverse patient effects were reported.Additional information was received which indicated that there was small myopotential noise on the shock channel due to an unknown source.Ts suspected it was caused by electromagnetic interference (emi) and recommended investigating the source as well as lead testing in clinic.This device 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.
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 implantable cardioverter defibrillator (icd) exhibited a high out of range shock lead impedance (sli) measurement of greater than 200 ohms.The sli returned to normal at the following daily measurement.Technical services (ts) recommended continuous monitoring.This device remains in service.No adverse patient effects were reported.Additional information was received which indicated that there was small myopotential noise on the shock channel due to an unknown source.Ts suspected it was caused by electromagnetic interference (emi) and recommended investigating the source as well as lead testing in clinic.This device remains in service.No adverse patient effects were reported.Additionally, the patient was seen in clinic for further testing.It was noted that when the patient sat still all shock vectors exhibited normal impedance measurements, however during isometrics and pocket manipulation the right ventricular (rv) coil exhibited shock impedance measurements of greater than 200 ohms.Baseline noise was also present; however, emi sources were ruled out.Ts recommended moving forward with a left vest for now.This 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 ; 6515826168
• MDR Report Key: 22806469
• Report Number: 2124215-2025-56842
• Device Sequence Number: 7797879
• Product Code: LWP
• UDI-Device Identifier: 00802526480768
• UDI-Public: (01)00802526480768(17)160118
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P960040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 07/09/2026

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: 01/18/2016
• Device Model Number: E161
• Device Catalogue Number: E161
• Device Lot Number: 105383
• 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: 07/31/2025
• Supplement Date Received by Manufacturer: 10/07/2025; 04/13/2026; 04/24/2026; 07/01/2026
• Initial Report FDA Received Date: 08/14/2025
• Supplement Report FDA Received Date: 10/08/2025; 04/14/2026; 04/27/2026; 07/10/2026
• Date Device Manufactured: 01/23/2014
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 36 YR
• Patient Sex: Female