MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENERGEN ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR DEVICE

Model Number	E141
Medical Device Problem Codes	Premature Discharge of Battery (1057); Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the battery of this implantable cardioverter defibrillator (icd) is suspected to be depleting prematurely with the longevity drop from 1.5 years to 3 months within a span of 5 months.Boston scientific technical services (ts) discussed no low voltage fault has been triggered but confirmed that the power consumption is increasing in a gradual fashion.This appears consistent with capacitor degradation due to hydrogen gas content in the sealed pg atmosphere.Ts recommends replacement within 90 days.This device remains in service.No adverse patient effects were reported.
Additional Manufacturer Narrative
Revision to the initial mdr in block b5 event description.This supplemental report was created to capture additional information.
Event or Problem Description
It was reported that the battery of this implantable cardioverter defibrillator (icd) is suspected to be depleting prematurely with the longevity drop from 1.5 years to 3 months within a span of 5 months.Boston scientific technical services (ts) discussed no low voltage fault has been triggered but confirmed that the power consumption is increasing in a gradual fashion.This appears consistent with capacitor degradation due to hydrogen gas content in the sealed pg atmosphere.Ts recommends replacement within 90 days.This device remains in service.No adverse patient effects were reported.Additional information indicates that this implantable cardioverter defibrillator (icd) was explanted and a new icd of a different model was placed.No additional adverse patient effects were reported.

• Brand Name: ENERGEN ICD
• Common Device Name: IMPLANTABLE CARDIOVERTER 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: 23000125
• Report Number: 2124215-2025-63135
• Device Sequence Number: 8869021
• Product Code: LWP
• UDI-Device Identifier: 00802526480720
• UDI-Public: (01)00802526480720(17)121227
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P960040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• 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
• Report Date (Section B): 02/12/2026

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: 12/27/2012
• Device Model Number: E141
• Device Catalogue Number: E141
• Device Lot Number: 101936
• 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: 08/14/2025
• Supplement Date Received by Manufacturer: 01/21/2026
• Initial Report FDA Received Date: 09/09/2025
• Supplement Report FDA Received Date: 02/12/2026
• Date Device Manufactured: 06/30/2011
• 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: 65 YR
• Patient Sex: Female