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

Model Number	G154
Medical Device Problem Codes	Pacing Problem (1439); Inappropriate/Inadequate Shock/Stimulation (1574); Delayed Charge Time (2586)
Health Effect - Clinical Code	Shock from Patient Lead(s) (3162)
Date of Event	04/27/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) delivered inappropriate therapy.Technical services (ts) was consulted, and it was found that multiple inappropriate anti-tachycardia pacing (atp) and shocks were provided.Therapy was exhausted.A delay in anti-tachycardia pacing (atp) delivery was also noted.In addition, reprogramming options for pacing outputs were recommended, as the safety margin was not met.No adverse patient effects were reported.This crt-d remains in service.
Additional Manufacturer Narrative
The local area sales representative was contacted for additional information as the physician's complete name and patient resolution.At this time, no further information is available.Should additional information become available this report will be updated.
Event or Problem Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) delivered inappropriate therapy.Technical services (ts) was consulted, and it was found that multiple inappropriate anti-tachycardia pacing (atp) and shocks were provided.Therapy was exhausted.A delay in anti-tachycardia pacing (atp) delivery was also noted.In addition, reprogramming options for pacing outputs were recommended, as the safety margin was not met.No adverse patient effects were reported.This crt-d remains in service.Additional information indicated that further reprogramming options were performed.No adverse patient effects were reported.This crt-d remains in service.
Additional Manufacturer Narrative
Good faith effort attempts were made to try and retrieve additional details regarding the reported event, including the physician's last name, but further information was unable to be obtained.At this time, no further information is available.Should additional information become available this report will be updated.

• 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: 22058090
• Report Number: 2124215-2025-32595
• Device Sequence Number: 8347983
• Product Code: NIK
• UDI-Device Identifier: 00802526534652
• UDI-Public: (01)00802526534652(17)201022(10)103611
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P010012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2025

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: 10/22/2020
• Device Model Number: G154
• Device Catalogue Number: G154
• Device Lot Number: 103611
• 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: 04/28/2025
• Supplement Date Received by Manufacturer: 05/23/2025
• Initial Report FDA Received Date: 05/21/2025
• Supplement Report FDA Received Date: 06/04/2025
• Date Device Manufactured: 11/29/2018
• 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
• Patient Age: 78 YR
• Patient Sex: Male