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

Model Number	E142
Medical Device Problem Codes	Battery Problem (2885); Interrogation Problem (4017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) exhibited a low battery and was unable to read this icd prior to reaching out the healthcare professional by a consult.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.

• 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: 23599064
• Report Number: 2124215-2025-84835
• Device Sequence Number: 18714933
• Product Code: LWP
• UDI-Device Identifier: 00802526480737
• UDI-Public: (01)00802526480737(17)150102
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P960040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• 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
• Report Date (Section B): 11/19/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/02/2015
• Device Model Number: E142
• Device Catalogue Number: E142
• Device Lot Number: 107539
• 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: 10/28/2025
• Initial Report FDA Received Date: 11/19/2025
• Date Device Manufactured: 01/04/2013
• 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
• Patient Age: 43 YR
• Patient Sex: Male