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

Model Number	G154
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) was exhibiting pacing impedance high out of range and continues to rise.The device remains in service.No additional adverse patient effects were reported.
Event or Problem Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) was exhibiting pacing impedance high out of range and continues to rise.The device remains in service.No additional adverse patient effects were reported.Additional information was obtained; the remote communicator displayed a red call doctor icon due to pacing lead impedance out of rang.

• 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: 21334313
• Report Number: 2124215-2025-06782
• Device Sequence Number: 8549872
• Product Code: NIK
• UDI-Device Identifier: 00802526534652
• UDI-Public: 00802526534652
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2025

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: 08/09/2020
• Device Model Number: G154
• Device Catalogue Number: G154
• Device Lot Number: 103395
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2025
• Supplement Date Received by Manufacturer: 08/08/2025
• Initial Report FDA Received Date: 02/07/2025
• Supplement Report FDA Received Date: 09/02/2025
• Date Device Manufactured: 08/24/2018
• 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: 73 YR
• Patient Sex: Male