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

Model Number	D150
Medical Device Problem Codes	Failure to Convert Rhythm (1540); Defibrillation/Stimulation Problem (1573); Under-Sensing (1661)
Health Effect - Clinical Code	Ventricular Fibrillation (2130)
Date of Event	09/05/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this implantable cardioverter defibrillator (icd) experienced a ventricular arrhythmia episode.It was noted that the patient initially presented with ventricular tachycardia (vt) and received shock therapy.Following the shock, the rhythm degenerated into ventricular fibrillation (vf).During the vf episode, intermittent undersensing was observed; however, the device ultimately detected the arrhythmia and delivered all available shock therapies.Despite therapy delivery, the arrhythmia was not terminated, and therapy was exhausted.The patient subsequently required external defibrillation to restore rhythm.Technical services (ts) was consulted and provided reprogramming recommendations for consideration.This device remains in service.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
If pertinent information is provided in the future, a supplemental report will be submitted.

• Brand Name: DYNAGEN? EL ICD VR
• 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 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: 50910784
• Report Number: 2124215-2026-51335
• Device Sequence Number: 12261715
• Product Code: LWS
• UDI-Device Identifier: 00802526534287
• UDI-Public: (01)00802526534287(17)200821
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P960040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

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: 08/21/2020
• Device Model Number: D150
• Device Catalogue Number: D150
• Device Lot Number: 242084
• 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: 09/09/2026
• Initial Report FDA Received Date: 09/28/2026
• Date Device Manufactured: 09/04/2018
• 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: Life Threatening; Other
• Patient Age: 41 YR
• Patient Sex: Male