MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DYNAGEN? CRT-D; CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR

Model Number	G154
Medical Device Problem Codes	Signal Artifact/Noise (1036); Over-Sensing (1438); Pacing Problem (1439); Low impedance (2285)
Health Effect - Clinical Code	Bradycardia (1751)
Date of Event	06/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) had the signal artifact monitoring (sam) sensor disable.Technical services (ts) was consulted and noted noise on the right ventricular (rv) lead which causes pacing inhibition and oversensing.Rv impedance drops twice around 100ohms.Ts suspects lead failure.Later on, the patient state to have a skin procedure the same day of the allegations.The device remains in service.No adverse patient effects were reported.
Event or Problem Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) had the signal artifact monitoring (sam) sensor disable.Technical services (ts) was consulted and noted noise on the right ventricular (rv) lead which causes pacing inhibition and oversensing.Rv impedance drops twice around 100ohms.Ts suspects lead failure.Later on, the patient state to have a skin procedure the same day of the allegations.The device remains in service.No adverse patient effects were reported.Additional information was obtained, the device was explanted and replaced due to normal battery depletion (nbd).

• Brand Name: DYNAGEN? CRT-D
• Common Device Name: CARDIAC RESYNCHRONIZATION THERAPY 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: 22346626
• Report Number: 2124215-2025-42835
• Device Sequence Number: 8520103
• Product Code: NIK
• UDI-Device Identifier: 00802526534652
• UDI-Public: (01)00802526534652(17)181206(10)101898
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P010012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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,Followup
• Report Date (Section B): 02/26/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 12/06/2018
• Device Model Number: G154
• Device Catalogue Number: G154
• Device Lot Number: 101898
• 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: 06/20/2025
• Supplement Date Received by Manufacturer: 02/18/2026
• Initial Report FDA Received Date: 06/27/2025
• Supplement Report FDA Received Date: 02/26/2026
• Date Device Manufactured: 12/22/2016
• 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
• Patient Age: 88 YR
• Patient Sex: Male