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

Model Number	G151
Medical Device Problem Codes	Signal Artifact/Noise (1036); Under-Sensing (1661)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device was not returned for analysis, as it remains implanted and in service; therefore, a technical analysis could not be performed.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of known inherent risk of device.If pertinent information is provided in the future, a supplemental report will be submitted.
Event or Problem Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) system exhibited noise on the non-boston scientific right atrial (ra) lead.Subsequently, atrial sensitivity was adjusted to a less sensitive setting, after which undersensing was observed.No adverse patient effects were reported.The crt-d remains in service.

• 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; 4100 hamline avenue north; saint paul MN 55112 5798
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 25478181
• Report Number: 2124215-2026-31352
• Device Sequence Number: 21123252
• Product Code: NIK
• UDI-Device Identifier: 00802526534638
• UDI-Public: (01)00802526534638(17)190517
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2026

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: 05/17/2019
• Device Model Number: G151
• Device Catalogue Number: G151
• Device Lot Number: 122250
• 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: 05/19/2026
• Supplement Date Received by Manufacturer: 06/25/2026
• Initial Report FDA Received Date: 06/11/2026
• Supplement Report FDA Received Date: 06/26/2026
• Date Device Manufactured: 05/31/2017
• 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: 71 YR
• Patient Sex: Male