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

Model Number	E143
Medical Device Problem Code	Delayed Charge Time (2586)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This product was manufactured before the implementation of the udi regulation, so the complete udi is unavailable.Applicable us product data has been included in this report.
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) had a charged time of 15.3 seconds and boston scientific technical services consultant (ts) discussed that this was secondary explant mechanism for patient's safety.As of this time, this icd remains in service.No adverse patient effects were reported.
Additional Manufacturer Narrative
This product was manufactured before the implementation of the udi regulation, so the complete udi is unavailable.Applicable us product data has been included in this report.
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) had a charged time of 15.3 seconds and boston scientific technical services consultant (ts) discussed that this was secondary explant mechanism for patient's safety.As of this time, this icd remains in service.No adverse patient effects were reported.Additional information received which indicates that this icd was explanted with no replacement and was returned for analysis.No additional adverse patient effects were reported.

• 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 degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 24500612
• Report Number: 2124215-2026-11777
• Device Sequence Number: 13251837
• Product Code: LWP
• UDI-Device Identifier: 00802526480744
• UDI-Public: (01)00802526480744(17)150610
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P960040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2026

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: 06/10/2015
• Device Model Number: E143
• Device Catalogue Number: E143
• Device Lot Number: 108282
• 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: 02/06/2026
• Supplement Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 03/03/2026
• Supplement Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/13/2013
• 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: Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male