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

Model Number	N140
Medical Device Problem Codes	High impedance (1291); Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) reached the explant indicator earlier than expected based on prior longevity estimates.Technical services (ts) reviewed the data and noted that the explant indicator was triggered due to high voltage charge times exceeding 15 seconds on multiple occasions.Engineering analysis confirmed the device is depleting normally and that this represents a secondary mechanism for reaching elective replacement indicator (eri), not reflected in standard longevity projections.A prior out-of-range shock impedance alert was also noted.Device replacement within the normal elective replacement indicator (eri) to end-of-life window was recommended.No adverse patient effects were reported.This crt-d remains in service.
Additional Manufacturer Narrative
Follow up report 1 (additional information): this report is being submitted to update field b5: describe event or problem, section b and field h6: device codes, section h.
Event or Problem Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) reached the explant indicator earlier than expected based on prior longevity estimates.Technical services (ts) reviewed the data and noted that the explant indicator was triggered due to high voltage charge times exceeding 15 seconds on multiple occasions.Engineering analysis confirmed the device is depleting normally and that this represents a secondary mechanism for reaching elective replacement indicator (eri), not reflected in standard longevity projections.A prior high out-of-range shock impedance alert was also noted.Device replacement within the normal elective replacement indicator (eri) to end-of-life window was recommended.No adverse patient effects were reported.This crt-d remains in service.Additional information was received that this crt-d was successfully explanted reached and replaced.No additional adverse patient effects were reported outside.

• 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: 24627317
• Report Number: 2124215-2026-14952
• Device Sequence Number: 8853176
• Product Code: LWP
• UDI-Device Identifier: 00802526480959
• UDI-Public: (01)00802526480959(17)160221
• 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: 2015
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2026

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: 02/21/2016
• Device Model Number: N140
• Device Catalogue Number: N140
• Device Lot Number: 113613
• 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: 03/05/2026
• Supplement Date Received by Manufacturer: 04/21/2026
• Initial Report FDA Received Date: 03/18/2026
• Supplement Report FDA Received Date: 04/30/2026
• Date Device Manufactured: 02/26/2014
• 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: 79 YR
• Patient Sex: Female