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

Model Number	N161
Medical Device Problem Codes	Signal Artifact/Noise (1036); Over-Sensing (1438); Pacing Problem (1439)
Health Effect - Clinical Code	Asystole (4442)
Date of Event	04/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) system oversensed noise on the right ventricular (rv) lead, which resulted in pacing inhibition and inappropriate anti-tachycardia pacing (atp).The patient experienced greater than two seconds of asystole.Technical services (ts) reviewed the stored episodes and noted the noise was suggests of electromagnetic interference (emi), however, the cause of the emi is unknown.This crt-d system remains in service.No additional adverse patient effects were reported.
Event or Problem Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) system oversensed noise on the right ventricular (rv) lead, which resulted in pacing inhibition and inappropriate anti-tachycardia pacing (atp).The patient experienced greater than two seconds of asystole.Technical services (ts) reviewed the stored episodes and noted the noise was suggests of electromagnetic interference (emi), however, the cause of the emi is unknown.This crt-d system remains in service.No additional adverse patient effects were reported.Additional information was received that this patient was seen in clinic due to the recurrence of emi suggestive episodes.The patient brought in their continuous positive airway pressure (cpap) machine; however the noise was unable to be reproduced.It was speculated that the device could be sensing atrial signals, but not confirmed.It was noted that no further action would be taken at this time.This crt-d system remains in service.No adverse patient effects were reported.
Event or Problem Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) system oversensed noise on the right ventricular (rv) lead, which resulted in pacing inhibition and inappropriate anti-tachycardia pacing (atp).The patient experienced greater than two seconds of asystole.Technical services (ts) reviewed the stored episodes and noted the noise was suggests of electromagnetic interference (emi), however, the cause of the emi is unknown.This crt-d system remains in service.No additional adverse patient effects were reported.Additional information was received that this patient was seen in clinic due to the recurrence of emi suggestive episodes.The patient brought in their continuous positive airway pressure (cpap) machine; however the noise was unable to be reproduced.It was speculated that the device could be sensing atrial signals but not confirmed.It was noted that no further action would be taken at this time.This crt-d system remains in service.No adverse patient effects were reported.Additional information was received that this device was explanted due to normal battery depletion.This device has been received for analysis.Other than the surgical procedure, no additional adverse patient effects were reported.The "no problem detected" conclusion code was selected based on analysis of the returned product.Analysis found no evidence of device anomaly outside the bounds of normal medical use.

• 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 ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 19878713
• Report Number: 2124215-2024-47542
• Device Sequence Number: 17913813
• Product Code: LWP
• UDI-Device Identifier: 00802526481000
• UDI-Public: 00802526481000
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P010012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/30/2025

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: 05/15/2016
• Device Model Number: N161
• Device Catalogue Number: N161
• Device Lot Number: 501348
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2024
• Supplement Date Received by Manufacturer: 10/09/2024; 07/24/2025
• Initial Report FDA Received Date: 07/31/2024
• Supplement Report FDA Received Date: 10/31/2024; 07/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2014
• 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
• Patient Age: 75 YR
• Patient Sex: Male