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

Model Number	G154
Medical Device Problem Codes	Over-Sensing (1438); Pacing Problem (1439); Under-Sensing (1661)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an atrial tachy response (atr) episode, this cardiac resynchronization therapy defibrillator (crt-d) delivered inappropriate pacing in the right atrial (ra) lead channel, which led to blanking of the intrinsic ventricular activity and inappropriate pacing in the right ventricular (rv) lead channel as well.Technical services (ts) was consulted, and programming enhancements were discussed.No adverse patient effects were reported.This device remains in service.
Event or Problem Description
It was reported that during an atrial tachy response (atr) episode, this cardiac resynchronization therapy defibrillator (crt-d) delivered inappropriate pacing in the right atrial (ra) lead channel, which led to blanking of the intrinsic ventricular activity and inappropriate pacing in the right ventricular (rv) lead channel as well.Technical services (ts) was consulted, and programming enhancements were discussed.No adverse patient effects were reported.This device remains in service.Additional information was received, the health care professional (hcp) requested a review of the presenting electrogram (egm) for this crt-d.Technical services (ts) discussed the presenting showed crosstalk oversensing of ventricular pacing in the atrial channel.Ts recommended possible reprogramming options.This crt-d remains in service.No adverse patient effects were reported.

• 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 ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 21369248
• Report Number: 2124215-2025-07960
• Device Sequence Number: 15562153
• Product Code: NIK
• UDI-Device Identifier: 00802526534652
• UDI-Public: (01)00802526534652(17)210312(10)103984(21)103984
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 05/12/2025

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: 03/12/2021
• Device Model Number: G154
• Device Catalogue Number: G154
• Device Lot Number: 103984
• 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: 01/30/2025
• Supplement Date Received by Manufacturer: 05/01/2025
• Initial Report FDA Received Date: 02/12/2025
• Supplement Report FDA Received Date: 05/12/2025
• Date Device Manufactured: 04/08/2019
• 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: 48 YR
• Patient Sex: Female