MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DYNAGEN? MINI ICD VR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number	D020
Medical Device Problem Code	Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Codes	Discomfort (2330); Shock from Patient Lead(s) (3162); Syncope/Fainting (4411)
Date of Event	12/02/2025
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 the patient with this implantable cardioverter defibrillator (icd) experienced a syncopal episode and discomfort.The icd was suspected of delivering an inappropriate shock; however, the suspected episode could not be viewed due to a battery capacity depleted (bcd) alert.Technical services (ts) recommended replacing the device.Subsequently, this icd was explanted and replaced due to normal battery depletion (nbd).No additional adverse patient effects were reported, and this icd has not been returned for analysis.

• Brand Name: DYNAGEN? MINI ICD VR
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• 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 ; 6515826168
• MDR Report Key: 23864807
• Report Number: 2124215-2025-92305
• Device Sequence Number: 12098283
• Product Code: LWS
• UDI-Device Identifier: 00802526533860
• UDI-Public: (01)00802526533860(17)171005
• 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: 2015
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/22/2025

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: 10/05/2017
• Device Model Number: D020
• Device Catalogue Number: D020
• Device Lot Number: 209129
• 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: 12/02/2025
• Initial Report FDA Received Date: 12/22/2025
• Date Device Manufactured: 10/05/2015
• 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: 56 YR
• Patient Sex: Female