MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DYNAGEN? MINI ICD DR; Implantable Cardioverter Defibrillator (ICD)

Model Number	D022
Medical Device Problem Codes	Pacing Problem (1439); Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Code	Shock from Patient Lead(s) (3162)
Date of Event	07/24/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) delivered potential inappropriate therapy for an atrial arrythmia.Inappropriate atp and shock therapy.Technical services (ts) reviewed the available device data and determined that the episodes were consistent with atrial fibrillation (af) with rapid ventricular response (rvr).Two episodes resulted in a total of two anti-tachycardia pacing (atp) bursts and four electric shocks delivered.Reprogramming options were provided and the physician planned to initiate amiodarone therapy.No additional adverse patient effects were reported.This icd remains in service.

• Brand Name: DYNAGEN? MINI 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 E91 T 862; EI E91 T862
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(651)582-6168
• MDR Report Key: 50358902
• Report Number: 2124215-2026-45012
• Device Sequence Number: 10103231
• Product Code: LWS
• UDI-Device Identifier: 00802526533907
• UDI-Public: (01)00802526533907(17)271015
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/20/2026

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: D022
• Device Catalogue Number: D022
• Device Lot Number: 143560
• 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: Not provided
• Initial Report FDA Received Date: 08/20/2026
• Date Device Manufactured: 10/21/2025
• 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: 64 YR
• Patient Sex: Female