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

Model Number	D020
Medical Device Problem Codes	Over-Sensing (1438); Pacing Problem (1439)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If pertinent information is provided in the future, a supplemental report will be submitted.
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) and right ventricular (rv) lead delivered inappropriate anti-tachycardia pacing (atp) due to myopotential oversensing on the shock channel.Technical services (ts) reviewed and provided reprograming options.This icd and rv lead remain in service.No adverse patient effects were reported.

• Brand Name: DYNAGEN? MINI 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: 25612028
• Report Number: 2124215-2026-33645
• Device Sequence Number: 5520880
• Product Code: LWS
• UDI-Device Identifier: 00802526533860
• UDI-Public: (01)00802526533860(17)191213
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2026

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: 12/13/2019
• Device Model Number: D020
• Device Catalogue Number: D020
• Device Lot Number: 216329
• 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: 06/01/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/24/2026
• Supplement Report FDA Received Date: 08/24/2026
• Date Device Manufactured: 01/10/2018
• 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
• Patient Age: 49 YR
• Patient Sex: Male