MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INCEPTA CRT-D; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

Model Number	N161
Medical Device Problem Codes	High impedance (1291); Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Code	Shock from Patient Lead(s) (3162)
Date of Event	12/12/2013
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) delivered inappropriate shock therapy with no therapy exhaustion.It was noted that the right ventricular (rv) lead was surgically abandoned and replaced due to out-of-range pace impedance measurements greater than 2,000 ohms, which were reproducible via pacing system analyzer (psa) testing.Additional information received reported that this icd delivered inappropriate shock for either sinus tachycardia or supraventricular tachycardia.The rhythm was 1:1 and atrial driven.A subsequent inappropriate shock was observed at the time of report.Technical services (ts) recommended that the health care professional (hcp) consult with cardiology for further evaluation and reprogramming options.This icd remains in service.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
The local area field representative was contacted for additional information regarding event cause and resolution.At this time, no further information is available.Should additional information become available this report will be updated.
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 this device exhibited intermittent fluctuations in impedance measurements with no conclusive evidence of a product performance issue; please refer to the description for more information regarding the specific circumstances of this event.
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) delivered inappropriate shock therapy with no therapy exhaustion.It was noted that the right ventricular (rv) lead was surgically abandoned and replaced due to out-of-range pace impedance measurements greater than 2,000 ohms, which were reproducible via pacing system analyzer (psa) testing.Additional information received reported that this icd delivered inappropriate shock for either sinus tachycardia or supraventricular tachycardia.The rhythm was 1:1 and atrial driven.A subsequent inappropriate shock was observed at the time of report.Technical services (ts) recommended that the health care professional (hcp) consult with cardiology for further evaluation and reprogramming options.This icd remains in service.No additional adverse patient effects were reported.

• Brand Name: INCEPTA CRT-D
• Common Device Name: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
• 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 degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 23243531
• Report Number: 2124215-2025-71263
• Device Sequence Number: 21435954
• Product Code: LWP
• UDI-Device Identifier: 00802526481000
• UDI-Public: (01)00802526481000(17)150916
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P010012
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2026

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: 09/16/2015
• Device Model Number: N161
• Device Catalogue Number: N161
• Device Lot Number: 499105
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2025
• Supplement Date Received by Manufacturer: 01/28/2026
• Initial Report FDA Received Date: 10/08/2025
• Supplement Report FDA Received Date: 02/13/2026
• Date Device Manufactured: 09/20/2013
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 44 YR
• Patient Sex: Female