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

Model Number	D020
Medical Device Problem Codes	Defibrillation/Stimulation Problem (1573); Failure to Read Input Signal (1581); Under-Sensing (1661)
Health Effect - Clinical Codes	Malaise (2359); Syncope/Fainting (4411)
Date of Event	06/03/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 the patient with this implantable cardioverter defibrillator (icd) contacted emergency medical services (ems) due to not feeling well.The patient subsequently lost consciousness while pulling into the emergency room (er) and speaking with paramedics and did not regain consciousness.The patient was transported to a medical facility where device interrogation was performed.The interrogation revealed this icd exhibited undersensing of ventricular fibrillation (vf).Technical services (ts) reviewed the data and determined the initial episode consisted of fine vf with signal amplitudes below the programmed rate cut off.Intermittent tall-short contributed to the undersensing, which resulted in inappropriate detection within the ventricular tachycardia (vt) zone.During the subsequent episode, the device detected tachyarrhythmia but did not consistently deliver therapy.Device logs documented that no therapy was delivered for multiple therapy attempts, with only one anti-tachycardia pacing (atp) and one shock delivered, despite the continued arrhythmia.Therapy attempts were exhausted while the arrhythmia persisted.It was suspected, but not confirmed, that a magnet may have been placed over the device.External defibrillation was reported to have terminated the arrhythmia.The patient was admitted to the intensive care unit (icu) and experienced prolong oxygen deprivation.No additional adverse patient effects were reported.This icd remains in service.

• 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: mark mischke ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(612)875-7234
• MDR Report Key: 25659557
• Report Number: 2124215-2026-34601
• Device Sequence Number: 10458726
• Product Code: LWS
• UDI-Device Identifier: 00802526533860
• UDI-Public: (01)00802526533860(17)220618
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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,Followup,Followup
• Report Date (Section B): 09/09/2026

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: 06/18/2022
• Device Model Number: D020
• Device Catalogue Number: D020
• Device Lot Number: 226034
• 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: 06/04/2026
• Supplement Date Received by Manufacturer: 06/30/2026; 08/27/2026
• Initial Report FDA Received Date: 06/29/2026
• Supplement Report FDA Received Date: 06/30/2026; 09/09/2026
• Date Device Manufactured: 07/02/2020
• 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: Other; Hospitalization
• Patient Age: 56 YR
• Patient Sex: Female