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

Model Number	N141
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that that this cardiac resynchronization therapy defibrillator (crt-d) is suspected to be depleting prematurely and reached elective replacement indicator (eri) after indicating months remaining.Boston scientific technical services (ts) discussed likely due to charge time (ct).This device remains in service.No adverse patient effects were reported.
Event or Problem Description
It was reported that that this cardiac resynchronization therapy defibrillator (crt-d) is suspected to be depleting prematurely and reached elective replacement indicator (eri) after indicating months remaining.Boston scientific technical services (ts) discussed likely due to charge time (ct).This device remains in service.No adverse patient effects were reported.Additional information indicates that this device was explanted.A new cardiac resynchronization therapy defibrillator (crt-d) with a different model was implanted successfully.No additional adverse patient effects were reported.

• Brand Name: ENERGEN? CRT-D
• Common Device Name: CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR DEVICE
• 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: 22432820
• Report Number: 2124215-2025-45192
• Device Sequence Number: 3163884
• Product Code: LWP
• UDI-Device Identifier: 00802526480966
• UDI-Public: (01)00802526480966(17)151001
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P010012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2025

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: 10/01/2015
• Device Model Number: N141
• Device Catalogue Number: N141
• Device Lot Number: 111430
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2025
• Supplement Date Received by Manufacturer: 06/30/2025
• Initial Report FDA Received Date: 07/08/2025
• Supplement Report FDA Received Date: 07/21/2025
• Date Device Manufactured: 10/07/2013
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 68 YR
• Patient Sex: Male