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

Model Number	N160
Medical Device Problem Codes	No Audible Alarm (1019); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) emitted beeping tones and the therapy has been programmed off for some time.Field representative did not have any information when the therapy was programmed off.As of this time, this device remains in service.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
This report is being submitted to correct the bsc aware date.In addition, this supplemental correction report was created to capture the additional information received which indicates that there were no issues on the device and the device was programmed off as per physician.This observation no longer meets the definition of malfunction as it was confirmed that the device was operating normally.Amending mdr decision to mdr=no report.This report is being submitted to correct the device codes field (f10) in section f, for use by uf/importer and device codes field (h6) in section h, device manufacturers only.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) emitted beeping tones and the therapy has been programmed off for some time.Field representative did not have any information when the therapy was programmed off.As of this time, this device remains in service.No adverse patient effects were reported.Additional information received which indicates that this icd was explanted, replaced with different model, and was returned for analysis.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
This report is being submitted to correct the device codes field (f10) in section f, for use by uf/importer and device codes field (h6) in section h, device manufacturers only.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) emitted beeping tones and the therapy has been programmed off for some time.Field representative did not have any information when the therapy was programmed off.As of this time, this device remains in service.No adverse patient effects were reported.Additional information received which indicates that this icd was explanted, replaced with different model, and was returned for analysis.No additional adverse patient effects were reported.

• Brand Name: INCEPTA CRT-D
• Common Device Name: IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY 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: 18418452
• Report Number: 2124215-2023-74335
• Device Sequence Number: 20800140
• Product Code: LWP
• UDI-Device Identifier: 00802526480997
• UDI-Public: 00802526480997
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/20/2026

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: 01/13/2016
• Device Model Number: N160
• Device Catalogue Number: N160
• Device Lot Number: 940965
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/11/2023
• Supplement Date Received by Manufacturer: 02/06/2026; 03/19/2026
• Initial Report FDA Received Date: 12/29/2023
• Supplement Report FDA Received Date: 03/20/2026; 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2014
• 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: Required Intervention; Hospitalization
• Patient Age: 79 YR
• Patient Sex: Female