MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENERGEN? ICD; implantable cardioverter defibrillator

Model Number	E141
Medical Device Problem Codes	Failure to Convert Rhythm (1540); Failure to Read Input Signal (1581)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This product investigation is still in progress.This report will be updated when product investigation is complete.
Event or Problem Description
It was reported that this patient with this implantable cardioverter defibrillator (icd) had a ventricular tachycardia (vt) arrhythmia.Anti-tachycardia pacing was provided appropriately but was ineffective.A shock was delivered and slowed the vt arrhythmia but did not terminate it.Subsequently, the vt arrhythmia spontaneously self-terminated.Technical services advised the amplitude is quite low and there was a complete morphology change.Additional information has been requested but was not provided at this time.This icd remains in service.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 ; +1(651)582-6168
• MDR Report Key: 25586189
• Report Number: 2124215-2026-33143
• Device Sequence Number: 5652023
• Product Code: LWP
• UDI-Device Identifier: 00802526480720
• UDI-Public: (01)00802526480720(17)130902
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P960040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2026

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: 09/02/2013
• Device Model Number: E141
• Device Catalogue Number: E141
• Device Lot Number: 115055
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2026
• Supplement Date Received by Manufacturer: 08/13/2026
• Initial Report FDA Received Date: 06/22/2026
• Supplement Report FDA Received Date: 08/14/2026
• Date Device Manufactured: 03/06/2012
• 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: 61 YR
• Patient Sex: Male