MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DYNAGEN MINI ICD VR; Implantable Cardioverter Defibrillator (Non-Crt)

Model Number	D020
Medical Device Problem Codes	Signal Artifact/Noise (1036); High impedance (1291); Over-Sensing (1438); Pacing Problem (1439); Inappropriate/Inadequate Shock/Stimulation (1574); Failure to Read Input Signal (1581)
Health Effect - Clinical Codes	Shock from Patient Lead(s) (3162); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2026
Type of Reportable Event	Malfunction
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 with high out-of-range shock impedance measurements greater than 200 ohms on the right ventricular (rv) defibrillation lead.Inappropriate anti-tachycardia pacing (atp) was delivered, and rv rate sensing had dropped significantly with pace impedance measurements decreasing from 400 ohms to less than 200 ohms.There were numerous ventricular tachycardia (vt) and ventricular fibrillation (vf) episodes containing non-physiologic noise on the rv rate sense and shock egms.Technical services (ts) discussed troubleshooting options, recommended an in-office check to evaluate rv lead integrity.This icd system remains in service.No adverse patient effects were reported.

• Brand Name: DYNAGEN MINI ICD VR
• Common Device Name: Implantable Cardioverter Defibrillator (Non-Crt)
• 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: 25383162
• Report Number: 2124215-2026-29779
• Device Sequence Number: 9188002
• Product Code: LWS
• UDI-Device Identifier: 00802526533860
• UDI-Public: (01)00802526533860(17)251106
• 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: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/17/2026

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: 11/06/2025
• Device Model Number: D020
• Device Catalogue Number: D020
• Device Lot Number: 238184
• 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: 05/04/2026
• Supplement Date Received by Manufacturer: 07/29/2026; 08/05/2026
• Initial Report FDA Received Date: 06/03/2026
• Supplement Report FDA Received Date: 08/03/2026; 08/17/2026
• Date Device Manufactured: 12/06/2023
• 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: 36 YR
• Patient Sex: Male