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

Model Number	E141
Medical Device Problem Codes	High impedance (1291); Failure to Read Input Signal (1581)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) exhibited low intrinsic amplitude and high shock impedance out of range.The device remains in service.No adverse patient effects were reported.
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) exhibited low intrinsic amplitude and high shock impedance out of range.The device remains in service.No adverse patient effects were reported.Additional information was obtained, the right ventricular (rv) lead is suspected to have broken and having issues, is currently in service and no adverse patient effects were reported.
Additional Manufacturer Narrative
This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.Investigation of the available information determined this device exhibited oversensing of noise generate that is related to intermittent increases in impedance measurements.Additionally, engineering analysis and testing of returned products has identified that any repeated, small movements of the lead terminal ring can create wearing of the lead terminal ring and generate microscopic particles, which may accumulate and oxidize over time.This can impact the connection between the spring contact and the lead ring, resulting in intermittent changes in impedance measurements.Please refer to the description field for more information regarding the specific circumstances of this event.
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) exhibited low intrinsic amplitude and high shock impedance out of range.The device remains in service.No adverse patient effects were reported.Additional information was obtained, the right ventricular (rv) lead is suspected to have broken and having issues, is currently in service and no 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 ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 23296456
• Report Number: 2124215-2025-73114
• Device Sequence Number: 17359334
• Product Code: LWP
• UDI-Device Identifier: 00802526480720
• UDI-Public: (01)00802526480720(17)141009
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup,Followup
• Report Date (Section B): 02/27/2026

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: 10/09/2014
• Device Model Number: E141
• Device Catalogue Number: E141
• Device Lot Number: 119082
• 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: 09/19/2025
• Supplement Date Received by Manufacturer: 10/17/2025; 02/26/2026
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 10/20/2025; 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/11/2012
• 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: 69 YR
• Patient Sex: Male