MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DYNAGEN? MINI ICD VR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number	D020
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	08/11/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) delivered anti-tachycardia pacing (atp) and shocks that may have been inappropriate.Technical services (ts) could not confirm whether or not this was caused by ventricular tachycardia (vt) or rapid ventricular response (rvr) due to the lack of atrial lead present.Based on presenting data, the device was functioning as programmed.This device remains in service.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
A good faith effort was made to retrieve additional information regarding resolution.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) delivered anti-tachycardia pacing (atp) and shocks that may have been inappropriate.Technical services (ts) could not confirm whether or not this was caused by ventricular tachycardia (vt) or rapid ventricular response (rvr) due to the lack of atrial lead present.Based on presenting data, the device was functioning as programmed.This device remains in service.No additional adverse patient effects were reported.Additional information was received that indicated no troubleshooting was performed as the device was performing as programmed.The patient's medication was adjusted to resolve.This device was subsequently explanted and replaced due to normal battery depletion.No adverse patient effects were reported.
Additional Manufacturer Narrative
A good faith effort was made to retrieve additional information regarding resolution.If information is provided in the future, a supplemental report will be issued.

• 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; 4100 hamline avenue north; saint paul MN 55112 5798
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 22907425
• Report Number: 2124215-2025-60348
• Device Sequence Number: 7932924
• Product Code: LWS
• UDI-Device Identifier: 00802526533860
• UDI-Public: (01)00802526533860(17)190131
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: P960040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2025

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: 01/31/2019
• Device Model Number: D020
• Device Catalogue Number: D020
• Device Lot Number: 212806
• 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: 08/11/2025
• Supplement Date Received by Manufacturer: 09/02/2025
• Initial Report FDA Received Date: 08/27/2025
• Supplement Report FDA Received Date: 09/03/2025
• Date Device Manufactured: 02/08/2017
• 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
• Patient Age: 65 YR
• Patient Sex: Female