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	06/20/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the battery of this implantable cardioverter defibrillator (icd) had dropped from 2 years to 23 months within the span of 3 months.Boston scientific technical services (ts) analysis 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 and suggested device replacement.This device remains in service.No adverse patient effects were reported.
Event or Problem Description
It was reported that the battery of this implantable cardioverter defibrillator (icd) had dropped from 2 years to 23 months within the span of 3 months.Boston scientific technical services (ts) analysis 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 and suggested device replacement.This device remains in service.No adverse patient effects were reported.Additional information indicates that this device was explanted due to product performance issue.A new implantable cardioverter defibrillator (icd) with a different model was implanted successfully.No additional adverse patient effects were reported.
Event or Problem Description
It was reported that the battery of this implantable cardioverter defibrillator (icd) had dropped from 2 years to 23 months within the span of 3 months.Boston scientific technical services (ts) analysis 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 and suggested device replacement.This device remains in service.No adverse patient effects were reported.Additional information indicates that this device was explanted.A new implantable cardioverter defibrillator (icd) with a different model was implanted successfully.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
The returned device was thoroughly inspected and analyzed.Review of device memory confirmed that a low voltage alert code 1003 was recorded.A high current drain was detected.Detailed analysis confirmed the identified high current drain was a result of compromised low voltage capacitors.Low voltage capacitors are used in the device's high voltage charging operation in order to facilitate fast charge times.Investigation has determined that the low voltage capacitors can become compromised due to the presence of excess hydrogen gas within the device case.The issue with these capacitors resulted in a high current drain, which was depleting this device's battery faster than normal.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 premature discharge of battery 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.

• 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: 22503083
• Report Number: 2124215-2025-47068
• Device Sequence Number: 21143925
• Product Code: LWP
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P960040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification,Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/01/2026

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: 09/29/2016
• Device Model Number: E141
• Device Catalogue Number: E141
• Device Lot Number: 126745
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2025
• Supplement Date Received by Manufacturer: 07/01/2025; 06/15/2026
• Initial Report FDA Received Date: 07/14/2025
• Supplement Report FDA Received Date: 07/29/2025; 07/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/08/2014
• 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: Required Intervention; Hospitalization
• Patient Age: 59 YR
• Patient Sex: Male