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

Model Number	D022
Medical Device Problem Codes	Device Difficult to Program or Calibrate (1496); Inappropriate/Inadequate Shock/Stimulation (1574); Interrogation Problem (4017)
Health Effect - Clinical Code	Shock from Patient Lead(s) (3162)
Date of Event	09/19/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this interrogation of this implantable cardioverter defibrillator (icd) was unsuccessful due to limited battery capacity, as the icd had reached elective replacement indicator (eri) in (b)(6) 2025.It was noted that the patient had several stored episodes where tachy shocks were delivered, and once instance where there was known atrial fibrillation (af) with rapid ventricular response (rvr).Subsequently, this icd was explanted and replaced for elective replacement time (ert) and returned for analysis.No adverse patient effects were reported.
Additional Manufacturer Narrative
The product has been received for analysis.This report will be updated upon completion of analysis.
Event or Problem Description
It was reported that this interrogation of this implantable cardioverter defibrillator (icd) was unsuccessful due to limited battery capacity, as the icd had reached elective replacement indicator (eri) in (b)(6) 2025.It was noted that the patient had several stored episodes where tachy shocks were delivered, and one instance where there was known atrial fibrillation (af) with rapid ventricular response (rvr).Subsequently, this icd was explanted and replaced for elective replacement time (ert), and returned for analysis.No adverse patient effects were reported.Additional information received reported that it was confirmed that inappropriate shocks had been delivered due to af with rvr prior to device changeout.This was also attributed to a single therapy zone due to the battery being at end of life (eol).The patient reportedly felt fine before the shocks, but it was also noted that she had been exerting herself.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
The product has been received for analysis.This report will be updated upon completion of analysis.

• 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 ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(651)582-6168
• MDR Report Key: 23329625
• Report Number: 2124215-2025-74351
• Device Sequence Number: 10611972
• Product Code: LWS
• UDI-Device Identifier: 00802526533907
• UDI-Public: (01)00802526533907(17)200516
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P960040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/07/2026

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: 05/16/2020
• Device Model Number: D022
• Device Catalogue Number: D022
• Device Lot Number: 115902
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/26/2025
• 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: 09/19/2025
• Supplement Date Received by Manufacturer: 10/20/2025; 07/30/2026
• Initial Report FDA Received Date: 10/17/2025
• Supplement Report FDA Received Date: 11/12/2025; 08/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2018
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 63 YR
• Patient Sex: Female