MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DYNAGEN CRT-D; IMPLANTABLE DEVICE

Model Number	G154
Medical Device Problem Codes	Pacing Problem (1439); Inappropriate/Inadequate Shock/Stimulation (1574); Inaccurate Synchronization (1609)
Health Effect - Clinical Codes	Ventricular Fibrillation (2130); Shock from Patient Lead(s) (3162)
Date of Event	10/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the cardiac resynchronization therapy defibrillator (crt-d) delivered inappropriate shocks and anti-tachycardia pacing (atp) due to supraventricular tachycardia (svt).Additionally, one atp reportedly accelerated the rate of the patient's arrhythmia into ventricular fibrillation (vf).A shock successfully converted the vf.The crt-d system remains in service.No additional adverse patient effects were reported.

• Brand Name: DYNAGEN CRT-D
• Common Device Name: IMPLANTABLE DEVICE
• 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: 20740843
• Report Number: 2124215-2024-73261
• Device Sequence Number: 8613919
• Product Code: NIK
• UDI-Device Identifier: 00802526534652
• UDI-Public: 00802526534652
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P010012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/20/2024

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: 03/20/2021
• Device Model Number: G154
• Device Catalogue Number: G154
• Device Lot Number: 104012
• 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: 10/29/2024
• Initial Report FDA Received Date: 11/20/2024
• Date Device Manufactured: 04/18/2019
• 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: Life Threatening
• Patient Age: 87 YR
• Patient Sex: Male