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

Model Number	N161
Medical Device Problem Codes	Delayed Charge Time (2586); Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) had a longevity of 11 months and dropped to elective replacement indicator (eri) in a span of 2 months.Boston scientific technical services (ts) confirmed that the device had a capacitor reform and charge time (ct) exceeded 15 seconds.The crt-d remains in service.No adverse patient effects were reported.
Event or Problem Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) had a longevity of 11 months and dropped to elective replacement indicator (eri) in a span of 2 months.Boston scientific technical services (ts) confirmed that the device had a capacitor reform and charge time (ct) exceeded 15 seconds.The crt-d remains in service.No adverse patient effects were reported.Additional information indicates that this cardiac resynchronization therapy defibrillator (crt-d) was explanted.A new crt-d with a different model was placed.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 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.A review of the device history record (dhr) was performed.The review of the dhr identified that there were no process related non-conformances, scrap, or rework performed during the production that could explain the event.The reviews ensure each device meets specification prior to release for use.There is no indication the device manufacturing process contributed to the reported complaint.A risk review was completed and confirmed that the event of gas gauge/longevity not as expected was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Review of labeling determined that the complaint situation was listed in the manual.There was no indication in the complaint that the product was not used in accordance to labeling.The manual was unlikely to be the cause of the reported complaint; translation, wording, or graphics does not require further review.
Event or Problem Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) had a longevity of 11 months and dropped to elective replacement indicator (eri) in a span of 2 months.Boston scientific technical services (ts) confirmed that the device had a capacitor reform and charge time (ct) exceeded 15 seconds.The crt-d remains in service.No adverse patient effects were reported.Additional information indicates that this cardiac resynchronization therapy defibrillator (crt-d) was explanted.A new crt-d with a different model was placed.No additional adverse patient effects were reported.

• Brand Name: INCEPTA? CRT-D
• Common Device Name: CARDIAC RESYNCHRONIZATION THERAPY WITH A 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: 22857377
• Report Number: 2124215-2025-58515
• Device Sequence Number: 9212392
• Product Code: LWP
• UDI-Device Identifier: 00802526481000
• UDI-Public: (01)00802526481000(17)160703
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/10/2026

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: 07/03/2016
• Device Model Number: N161
• Device Catalogue Number: N161
• Device Lot Number: 501573
• 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: 07/21/2025
• Supplement Date Received by Manufacturer: 09/09/2025; 02/19/2026
• Initial Report FDA Received Date: 08/20/2025
• Supplement Report FDA Received Date: 09/25/2025; 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/11/2014
• 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: Hospitalization; Required Intervention
• Patient Age: 88 YR
• Patient Sex: Male