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

Model Number	E143
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by the healthcare professional (hcp) that the battery of this implantable cardioverter defibrillator (icd) decreased from 10 months to 3 months in a span of 2 months.Technical services (ts) assessed and indicated that the power consumption measured at 34 microwatts, with no recent atrial fibrillation (af) episodes, capacitor reforms, excessive interrogations, or active advisories.A request was made to have data from this device analyzed.Data analysis confirmed that the device showed no low voltage fault, but depletion pattern matched the 2013 lv capacitors advisory.The battery voltage was 2.910 volts with therapy unaffected.The battery status indicators were inaccurate due to undetected energy loss.The device malfunction confirmed; replacement and return for analysis was recommended.The daily power fluctuations were steady, with sufficient reserve for 90 days before reassessment or replacement.This icd was explanted and replaced.No additional adverse patient effects were reported.
Event or Problem Description
It was reported by the healthcare professional (hcp) that the battery of this implantable cardioverter defibrillator (icd) decreased from 10 months to 3 months in a span of 2 months.Technical services (ts) assessed and indicated that the power consumption measured at 34 microwatts, with no recent atrial fibrillation (af) episodes, capacitor reforms, excessive interrogations, or active advisories.A request was made to have data from this device analyzed.Data analysis confirmed that the device showed no low voltage fault, but depletion pattern matched the 2013 lv capacitors advisory.The battery voltage was 2.910 volts with therapy unaffected.The battery status indicators were inaccurate due to undetected energy loss.The device malfunction confirmed; replacement and return for analysis was recommended.The daily power fluctuations were steady, with sufficient reserve for 90 days before reassessment or replacement.This icd was explanted and replaced.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
The returned device was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.Device memory was reviewed and no error codes were noted.The review of the device memory log showed a battery voltage greater than 2.7 volts with normal power usage while implanted, and all programmed therapies remained available during that time.Evaluation of the battery depletion curves demonstrated no evidence of intermittency or device faults, findings that are consistent with normal battery depletion.

• Brand Name: ENERGEN ICD
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• 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: 23245419
• Report Number: 2124215-2025-71315
• Device Sequence Number: 13324855
• Product Code: LWP
• UDI-Device Identifier: 00802526480744
• UDI-Public: (01)00802526480744(17)160211
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P960040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2025
• 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): 01/22/2026

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: 02/11/2016
• Device Model Number: E143
• Device Catalogue Number: E143
• Device Lot Number: 111202
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2025
• Supplement Date Received by Manufacturer: 12/31/2025
• Initial Report FDA Received Date: 10/08/2025
• Supplement Report FDA Received Date: 01/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/17/2014
• 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: 81 YR
• Patient Sex: Female