MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DYNAGEN? CRT-D; cardiac resynchronization therapy defibrillator (CRT-D)

Model Number	G150
Medical Device Problem Codes	Failure to Convert Rhythm (1540); Unexpected Therapeutic Results (1631)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	08/11/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) experienced a sudden cardiac arrest (sca).It was noted that all programmed therapy was exhausted during the event.Technical services (ts) was consulted, and it was reported that the local company representative planned to perform a consult transmission to obtain the stored episodes for further review.This device remains in service.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
If pertinent information is provided in the future, a supplemental report will be submitted.

• Brand Name: DYNAGEN? CRT-D
• Common Device Name: cardiac resynchronization therapy defibrillator (CRT-D)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): Boston Scientific Corporation; cashel road; clonmel E91 T 862; EI E91 T862
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(651)582-6168
• MDR Report Key: 50602083
• Report Number: 2124215-2026-45745
• Device Sequence Number: 10732671
• Product Code: NIK
• UDI-Device Identifier: 00802526534614
• UDI-Public: (01)00802526534614(17)250801
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: P010012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/25/2026

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: 08/01/2025
• Device Model Number: G150
• Device Catalogue Number: G150
• Device Lot Number: 518229
• 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: Not provided
• Initial Report FDA Received Date: 09/04/2026
• Date Device Manufactured: 08/24/2023
• 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: Hospitalization; Other
• Patient Age: 68 YR
• Patient Sex: Male