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

Model Number	N140
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If pertinent information is provided in the future, a supplemental report will be submitted.
Event or Problem Description
It was reported that during a generator change due to normal battery depletion for this cardiac resynchronization therapy defibrillator (crt-d) it was observed that the atrial and left ventricular (lv) leads were inverted in the header when implanted back in 2015.Subsequently, the procedure was completed successfully.This product is not expected to be returned.No adverse patient effects were reported.
Additional Manufacturer Narrative
This product was explanted and was not returned.As such, physical analysis has not been conducted in our laboratory.Based on a thorough review of the reported complaint, and in the absence of a product return, boston scientific has assigned an investigation conclusion code of "cause traced to intentional off-label, unapproved or contraindicated use".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 user used incorrect product for intended use 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.If pertinent information is provided in the future, a supplemental report will be submitted.
Event or Problem Description
It was reported that during a generator change due to normal battery depletion for this cardiac resynchronization therapy defibrillator (crt-d) it was observed that the atrial and left ventricular (lv) leads were inverted in the header when implanted back in 2015.Subsequently, the procedure was completed successfully.This product is not expected to be returned.No adverse patient effects were reported.

• Brand Name: ENERGEN? 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: 23452103
• Report Number: 2124215-2025-78924
• Device Sequence Number: 21125692
• Product Code: LWP
• UDI-Device Identifier: 00802526480959
• UDI-Public: (01)00802526480959(17)161125
• Combination Product (Y/N): N
• Initial Reporter State: PR
• 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
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 11/25/2016
• Device Model Number: N140
• Device Catalogue Number: N140
• Device Lot Number: 116174
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2025
• Supplement Date Received by Manufacturer: 03/18/2026
• Initial Report FDA Received Date: 11/03/2025
• Supplement Report FDA Received Date: 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/03/2014
• 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: 72 YR
• Patient Sex: Female