MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENERGEN? ICD; Implantable Cardioverter Defibrillator

Model Number	E142
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) had an anomaly regarding battery longevity as the patient was in questioned while being in the hospital.Boston scientific technical services consultant (ts) referred the patient to the device following physician.At this time, this icd remains in service.No adverse patient effects were reported.
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) had an anomaly regarding battery longevity as the patient was in questioned while being in the hospital.Boston scientific technical services consultant (ts) referred the patient to the device following physician.At this time, this icd remains in service.No adverse patient effects were reported.Additional information received indicates that this icd has reached elective replacement indicator and hospitalization was not related to our device.Subsequently, this icd was explanted and was replaced with different model.
Additional Manufacturer Narrative
This supplemental correction report was created to capture the additional information received which indicates that there were no anomalies on the device and no actions were taken.This observation no longer meets the definition of malfunction as it was confirmed that the device was operating normally.Amending mdr decision to mdr=no 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 E91 T 862; EI E91 T862
• Manufacturer Contact: mark mischke ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(612)875-7234
• MDR Report Key: 50601125
• Report Number: 2124215-2026-45691
• Device Sequence Number: 21515695
• Product Code: LWP
• UDI-Device Identifier: 00802526480737
• UDI-Public: (01)00802526480737(17)150130
• 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: 2013
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/29/2026

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: 01/30/2015
• Device Model Number: E142
• Device Catalogue Number: E142
• Device Lot Number: 108671
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 08/31/2026; 09/28/2026
• Initial Report FDA Received Date: 09/04/2026
• Supplement Report FDA Received Date: 09/09/2026; 09/29/2026
• Date Device Manufactured: 02/02/2013
• 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: 62 YR
• Patient Sex: Male