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

Model Number	E143
Medical Device Problem Codes	High impedance (1291); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) system recorded a code 1005, indicative of an open circuit condition detected during shock delivery due to a high out-of-range shock impedance measurement.Further testing and reprogramming options were recommended.No adverse patient effects were reported.This icd remains in service.
Additional Manufacturer Narrative
At this time, no further information is available.Should additional information become available this report will be updated.

• 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: 22070662
• Report Number: 2124215-2025-33066
• Device Sequence Number: 15628867
• Product Code: LWP
• UDI-Device Identifier: 00802526480744
• UDI-Public: (01)00802526480744(17)150215
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 05/22/2025

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: 02/15/2015
• Device Model Number: E143
• Device Catalogue Number: E143
• Device Lot Number: 106557
• 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: 05/08/2025
• Initial Report FDA Received Date: 05/22/2025
• Date Device Manufactured: 02/19/2013
• 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: 70 YR
• Patient Sex: Female