MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DYNAGEN CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D

Model Number	G151
Medical Device Problem Codes	Signal Artifact/Noise (1036); Pacing Problem (1439); Failure to Read Input Signal (1581); Under-Sensing (1661)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	02/23/2026
Type of Reportable Event	Death
Event or Problem Description
It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) was reported to have passed away on (b)(6) 2026.An initial review indicated the patient had four treated and one non-sustained ventricular tachycardia from the date of their passing.Boston scientific discussed these episodes with the field and confirmed there was evidence of undersensing of ventricular fibrillation (vf), which resulted in instances of inappropriate pacing.Low amplitude measurements were also noted in some of the episodes.Due to the timing of these episodes, it cannot be ruled out that undersensing and inappropriate pacing may have deteriorated the patient's condition, which inevitably led to their passing.All evidence indicates the crt-d remains in situ and no additional adverse patient effects were reported.
Additional Manufacturer Narrative
If pertinent information is provided in the future, a supplemental report will be submitted.
Additional Manufacturer Narrative
A risk review was completed and confirmed that the event of undersensing 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 summary: with all the available information, boston scientific concludes the allegations in this complaint have not been confirmed as there was not enough information provided in the complaint and the product has not been returned for analysis.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.Device technical analysis: this product has not been returned back to boston scientific, and as a result, laboratory analysis could not be conducted.Labeling review: review of labeling determined the complaint situation was listed in the manual.There was no indication in the complaint that the product was not used in accordance to labeling.The manual was unlikely to be the cause of the reported complaint; translation, wording, or graphics does not require further review.Investigation conclusion: the cause not established investigation conclusion was selected because the reason for the alleged observations could not be determined.
Event or Problem Description
It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) was reported to have passed away on (b)(6) 2026.An initial review indicated the patient had four treated and one non-sustained ventricular tachycardia from the date of their passing.Boston scientific discussed these episodes with the field and confirmed there was evidence of undersensing of ventricular fibrillation (vf), which resulted in instances of inappropriate pacing.Low amplitude measurements were also noted in some of the episodes.Due to the timing of these episodes, it cannot be ruled out that undersensing and inappropriate pacing may have deteriorated the patient's condition, which inevitably led to their passing.All evidence indicates the crt-d remains in situ and no additional adverse patient effects were reported.

• Brand Name: DYNAGEN CRT-D
• Common Device Name: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH 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 ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 24646192
• Report Number: 2124215-2026-15418
• Device Sequence Number: 10207430
• Product Code: NIK
• UDI-Device Identifier: 00802526534638
• UDI-Public: (01)00802526534638(17)220807
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P010012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2026

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: 08/06/2022
• Device Model Number: G151
• Device Catalogue Number: G151
• Device Lot Number: 141499
• 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: 02/25/2026
• Supplement Date Received by Manufacturer: 05/12/2026
• Initial Report FDA Received Date: 03/19/2026
• Supplement Report FDA Received Date: 05/18/2026
• Date Device Manufactured: 08/18/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 77 YR
• Patient Sex: Male