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

Model Number	D150
Medical Device Problem Code	Failure to Convert Rhythm (1540)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during implant procedure this implantable cardioverter defibrillator (icd) system failed defibrillation threshold (dft) testing as a result, the physician made the decision to use an additional coil and reprogram polarity.It was noted that this system was placed in a healthy amount of adipose tissue.This icd remains in service.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
This product investigation is still in progress.This report will be updated when product investigation is complete.

• 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 ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(651)582-6168
• MDR Report Key: 25567824
• Report Number: 2124215-2026-32990
• Device Sequence Number: 9995690
• Product Code: LWS
• UDI-Device Identifier: 00802526534287
• UDI-Public: (01)00802526534287(17)271007
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P960040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2026

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 Model Number: D150
• Device Catalogue Number: D150
• Device Lot Number: 367526
• 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: 05/27/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/19/2026
• Supplement Report FDA Received Date: 08/19/2026
• Date Device Manufactured: 10/14/2025
• 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: Hospitalization; Required Intervention
• Patient Age: 42 YR
• Patient Sex: Male