MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENERGEN? ICD; PACEMAKER

Model Number	E140
Medical Device Problem Codes	High impedance (1291); Off-Label Use (1494)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the health care professional (hcp) called for assistance with programming this implantable cardioverter defibrillator (icd) into magnetic resonance imaging (mri) protection mode.Technical services (ts) informed this is a non-conditional system due to high out of range shock impedance measurements and programmed this icd.After the mri was performed, this icd system was removed from the mri protection mode, it was confirmed that the device was functioning as intended.No adverse patient effects were reported.This icd remains in service.
Additional Manufacturer Narrative
This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.The associated investigation determined that there was no conclusive evidence that the observed out-of-range impedance measurements were due to a product performance issue or an inadequate lead-to-device connection.However, intermittent, out-of-range shock lead impedance measurements with no conclusive evidence of a performance issue or an inadequate lead-to-device connection are likely the result of the low-energy test signal utilized for daily automatic or in-clinic commanded shock lead impedance testing.A software update was released in 2015 to further improve consistency of the impedance test results and provide the clinician with additional diagnostic tools, including programmable shock lead impedance alert limits.A review of the device history record (dhr) was performed.The review of the dhr identified that there were no process related non-conformances, scrap, or rework performed during the production that could explain the event.The reviews ensure each device meets specification prior to release for use.There is no indication the device manufacturing process contributed to the reported complaint.A risk review was completed and confirmed that the event of shock impedance high out of range was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Review of labeling determined that the complaint situation was listed in the manual.The manual was unlikely to be the cause of the reported complaint; translation, wording, or graphics does not require further review.The "design inadequate for purpose" conclusion code was selected.
Event or Problem Description
It was reported that the health care professional (hcp) called for assistance with programming this implantable cardioverter defibrillator (icd) into magnetic resonance imaging (mri) protection mode.Technical services (ts) informed this is a non-conditional system due to high out of range shock impedance measurements and programmed this icd.After the mri was performed, this icd system was removed from the mri protection mode, it was confirmed that the device was functioning as intended.No adverse patient effects were reported.This icd remains in service.

• Brand Name: ENERGEN? ICD
• Common Device Name: PACEMAKER
• 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: 24194584
• Report Number: 2124215-2026-04856
• Device Sequence Number: 8010084
• Product Code: LWP
• UDI-Device Identifier: 00802526480713
• UDI-Public: (01)00802526480713(17)160724
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P960040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2026

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: 07/24/2016
• Device Model Number: E140
• Device Catalogue Number: E140
• Device Lot Number: 117484
• 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: 01/08/2026
• Supplement Date Received by Manufacturer: 06/12/2026
• Initial Report FDA Received Date: 01/27/2026
• Supplement Report FDA Received Date: 06/15/2026
• Date Device Manufactured: 07/31/2014
• 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
• Patient Age: 41 YR
• Patient Sex: Female