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

Model Number	N160
Medical Device Problem Code	Interrogation Problem (4017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a normal battery depletion device replacement this cardiac resynchronization therapy defibrillator (crt-d) was having interrogation issues.It was noted that the connection was sluggish and could not be maintained without physical proximity to the device.Multiple programmers and telemetry wands were attempted but did not resolve this.This device was subsequently explanted and replaced.This device has not been received for analysis.Other than the surgical procedure, no additional adverse patient effects were reported.
Additional Manufacturer Narrative
This crt-d was thoroughly inspected and analyzed upon receipt.Memory log review indicated that there were no suspicious fault or resets recorded.The device passed the longevity calculation and depletion was found to be normal.The device was put through and passed the returned product test as well as telemetry communication.Analysis found no evidence of device anomalies.
Event or Problem Description
It was reported that during a normal battery depletion device replacement this cardiac resynchronization therapy defibrillator (crt-d) was having interrogation issues.It was noted that the connection was sluggish and could not be maintained without physical proximity to the device.Multiple programmers and telemetry wands were attempted but did not resolve this.This device was subsequently explanted and replaced.This device has not been received for analysis.Other than the surgical procedure, 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 ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 22124501
• Report Number: 2124215-2025-35819
• Device Sequence Number: 12931343
• Product Code: LWP
• UDI-Device Identifier: 00802526480997
• UDI-Public: (01)00802526480997(17)150430
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2025

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: 04/30/2015
• Device Model Number: N160
• Device Catalogue Number: N160
• Device Lot Number: 899834
• 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: 05/20/2025
• Supplement Date Received by Manufacturer: 11/14/2025
• Initial Report FDA Received Date: 06/02/2025
• Supplement Report FDA Received Date: 11/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/07/2013
• 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: 86 YR
• Patient Sex: Male