MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INCEPTA CRT-D; CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D)

Model Number	N160
Medical Device Problem Codes	Failure to Capture (1081); High impedance (1291); Battery Problem (2885); Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this patient's pacemaker was beeping.Upon interrogation in clinic, it was found that the pacemaker was at its elective replacement indicator (eri).At last check approximately three months prior, the battery life estimate was one year left.An analysis of device data to determine battery status was declined.It was also found that the intrinsic amplitude of the left ventricular (lv) lead was high at greater than 25 mv along with intermittent loss of capture (loc) and high out of range pacing impedance measurements greater than 2500 ohms.No additional adverse patient effects were reported.Currently, this pacemaker system remains in service.
Event or Problem Description
It was reported that this patient's pacemaker was beeping.Upon interrogation in clinic, it was found that the pacemaker was at its elective replacement indicator (eri).At last check approximately three months prior, the battery life estimate was one year left.An analysis of device data to determine battery status was declined.It was also found that the intrinsic amplitude of the left ventricular (lv) lead was high at greater than 25 mv along with intermittent loss of capture (loc) and high out of range pacing impedance measurements greater than 2500 ohms.No additional adverse patient effects were reported.Currently, this pacemaker system remains in service.According to additional information, this cardiac resynchronization therapy defibrillator (crt-d) was explanted because it had reached eri status.A new crt-d was successfully placed.After fluoroscopy was performed, it was noted that there was a suspected break/fracture in the lead.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
The returned device was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.Visual examination of the device header and case noted no anomalies.The device was then exposed to simulated heart load conditions, and the defibrillation, pacing, and sensing functions were tested.Impedance testing was completed and all measurements were within normal limits.The device operated appropriately with no interruptions in therapy output at the returned programmed settings.A series of electrical tests was also performed, and again, normal device function was observed.Analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.
Event or Problem Description
It was reported that this patient's pacemaker was beeping.Upon interrogation in clinic, it was found that the pacemaker was at its elective replacement indicator (eri).At last check approximately three months prior, the battery life estimate was one year left.An analysis of device data to determine battery status was declined.It was also found that the intrinsic amplitude of the left ventricular (lv) lead was high at greater than 25 mv along with intermittent loss of capture (loc) and high out of range pacing impedance measurements greater than 2500 ohms.No additional adverse patient effects were reported.Currently, this pacemaker system remains in service.According to additional information, this cardiac resynchronization therapy defibrillator (crt-d) was explanted because it had reached eri status.A new crt-d was successfully placed.After fluoroscopy was performed, it was noted that there was a suspected break/fracture in the lead.No additional adverse patient effects were reported.

• Brand Name: INCEPTA CRT-D
• Common Device Name: CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D)
• 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: 21355891
• Report Number: 2124215-2025-07419
• Device Sequence Number: 18393223
• Product Code: LWP
• UDI-Device Identifier: 00802526480997
• UDI-Public: 00802526480997
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P010012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/02/2025

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: 12/10/2015
• Device Model Number: N160
• Device Catalogue Number: N160
• Device Lot Number: 938020
• 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: 01/29/2025
• Supplement Date Received by Manufacturer: 03/03/2025; 06/26/2025
• Initial Report FDA Received Date: 02/11/2025
• Supplement Report FDA Received Date: 03/04/2025; 07/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2013
• 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: Female