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

Model Number	G150
Medical Device Problem Codes	Over-Sensing (1438); Pacing Problem (1439); Use of Device Problem (1670); Data Problem (3196)
Health Effect - Clinical Code	Asystole (4442)
Date of Event	12/12/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this patient was undergoing an ablation procedure and the cardiac resynchronization therapy defibrillator (crt-d) was programmed into mri protection mode instead of electrocautery protection mode.During the ablation, pacing was inhibited for the patient due to oversensing of the pulse field energy from the ablation device.There was pacing inhibition greater than 2 seconds with asystole.The patient rhythm returned when ablation was paused.To continue the ablation procedure an electrophysiology (ep) catheter was used to pace.This ep catheter was placed in the venous access into the apex of the right ventricle.The ablation procedure was completed and the crt-d was operating as normal afterwards.All measurements were found to be within normal limits.This crt-d remains in service.No additional adverse patient effects were reported.
Event or Problem Description
It was reported that this patient was undergoing an ablation procedure and the cardiac resynchronization therapy defibrillator (crt-d) was programmed into mri protection mode instead of electrocautery protection mode.During the ablation, pacing was inhibited for the patient due to oversensing of the pulse field energy from the ablation device.There was pacing inhibition greater than 2 seconds with asystole.The patient rhythm returned when ablation was paused.To continue the ablation procedure an electrophysiology (ep) catheter was used to pace.This ep catheter was placed in the venous access into the apex of the right ventricle.The ablation procedure was completed and the crt-d was operating as normal afterwards.All measurements were found to be within normal limits.This crt-d remains in service.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Device technical analysis: this product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.Device history record review: a review of the device history record (dhr) was performed.The review of the dhr identified that there were no process related non-conformances, scrap, or rework performed during the production that could explain the event.The reviews ensure each device meets specification prior to release for use.There is no indication the device manufacturing process contributed to the reported complaint.Labeling review: review of labeling determined that the complaint situation was listed in the manual.The manual was unlikely to be the cause of the reported complaint; translation, wording, or graphics does not require further review.Risk assessment: a risk review was completed and confirmed that the event of brady pacing not delivered when required was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of unintended use error caused or contributed to event.

• 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: 24027612
• Report Number: 2124215-2026-01688
• Device Sequence Number: 21070942
• Product Code: NIK
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P010012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2026

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: 03/29/2026
• Device Model Number: G150
• Device Catalogue Number: G150
• Device Lot Number: 523032
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2025
• Supplement Date Received by Manufacturer: 06/08/2026
• Initial Report FDA Received Date: 01/09/2026
• Supplement Report FDA Received Date: 06/09/2026
• Date Device Manufactured: 04/17/2024
• 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: Required Intervention; Hospitalization
• Patient Age: 81 YR
• Patient Sex: Male