MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DYNAGEN? EL ICD DR; Implantable cardioverter defibrillator (ICD)

Model Number	D153
Medical Device Problem Codes	Pacing Problem (1439); Defibrillation/Stimulation Problem (1573); Under-Sensing (1661)
Health Effect - Clinical Code	Tachycardia (2095)
Date of Event	05/14/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The local area field representative was contacted for additional information regarding event cause and resolution.At this time, no further information is available.Should additional information become available this report will be updated.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 electrogram (egm) review was requested for this implantable cardioverter defibrillator (icd) system which stored a non-sustained ventricular tachycardia (nsvt) episode.Upon review, there was a ventricular beat that was blanked and a ventricular pace was delivered around the t-wave.It was suspected that the ventricular pace contributed to the arrhythmia.It was noted that a premature ventricular contraction (pvc) also occurred around the atrial pace and may have caused the arrhythmia as well.Other episodes without the ventricular pacing had a similar pattern.Technical services (ts) discussed troubleshooting options and programming considerations.This icd remains in service.No additional adverse patient effects were reported.

• Brand Name: DYNAGEN? EL ICD DR
• Common Device Name: Implantable cardioverter defibrillator (ICD)
• 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: 25486758
• Report Number: 2124215-2026-31541
• Device Sequence Number: 10315184
• Product Code: LWS
• UDI-Device Identifier: 00802526534829
• UDI-Public: (01)00802526534829(17)190925
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: P960040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/24/2019
• Device Model Number: D153
• Device Catalogue Number: D153
• Device Lot Number: 210307
• 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: 05/18/2026
• Supplement Date Received by Manufacturer: 08/11/2026
• Initial Report FDA Received Date: 06/12/2026
• Supplement Report FDA Received Date: 08/13/2026
• Date Device Manufactured: 10/24/2017
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 77 YR
• Patient Sex: Female