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

Model Number	G154
Medical Device Problem Code	Over-Sensing (1438)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) was oversensing atrial events on the ventricular channel.Technical services (ts) noted that the signal appeared to come in before any cross chamber blanking and recommended programming changes.No adverse patient effects were reported.This crt-d remains in service.

• 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: 20856050
• Report Number: 2124215-2024-76938
• Device Sequence Number: 15679822
• Product Code: NIK
• UDI-Device Identifier: 00802526534652
• UDI-Public: 00802526534652
• 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: 2022
• 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
• Report Date (Section B): 12/05/2024

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: Health Professional
• Device Expiration Date: 02/01/2023
• Device Model Number: G154
• Device Catalogue Number: G154
• Device Lot Number: 105632
• 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: 11/26/2024
• Initial Report FDA Received Date: 12/05/2024
• Date Device Manufactured: 03/09/2021
• 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: 56 YR
• Patient Sex: Male