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

Model Number	G150
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	Calcium Deposits/Calcification (1758)
Date of Event	06/12/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) system demonstrated a notable decrease in impedance compared to the last in clinic evaluation.A breakdown of the defibrillation vectors indicated directional changes consistent with evolving lead characteristics.Technical services reviewed historical system data and identified a gradual upward trend in baseline in shock lead impedance over several years.Based on the vector patterns and impedance trends, the findings suggest significant calcification of the proximal coil relative to the distal coil.A defibrillation threshold test (dft) should be considered to ensure the system remains effective in a single coil configuration.The healthcare provider acknowledged and understood the recommendation.This device remains in service.This device was not returned for analysis.The product investigation determined that the "known inherent risk of device" investigation conclusion code was selected based on product record and reported observation review.Additional information was received that this crt-d was explanted and returned for analysis.Other than the surgical procedure, no additional adverse patient effects were reported.
Event or Problem Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) system demonstrated a notable decrease in impedance compared to the last in clinic evaluation.A breakdown of the defibrillation vectors indicated directional changes consistent with evolving lead characteristics.Technical services reviewed historical system data and identified a gradual upward trend in baseline in shock lead impedance over several years.Based on the vector patterns and impedance trends, the findings suggest significant calcification of the proximal coil relative to the distal coil.A defibrillation threshold test (dft) should be considered to ensure the system remains effective in a single coil configuration.The healthcare provider acknowledged and understood the recommendation.This device remains in service.This device was not returned for analysis.The product investigation determined that the "known inherent risk of device" investigation conclusion code was selected based on product record and reported observation review.Additional information was received that this crt-d was explanted and returned for analysis.Other than the surgical procedure, 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: 23359652
• Report Number: 2124215-2025-75672
• Device Sequence Number: 12979515
• Product Code: NIK
• UDI-Device Identifier: 00802526534614
• UDI-Public: (01)00802526534614(17)190711
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: P010012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2025
• 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): 01/05/2026

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: 07/11/2019
• Device Model Number: G150
• Device Catalogue Number: G150
• Device Lot Number: 487338
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2025
• Supplement Date Received by Manufacturer: 12/31/2025
• Initial Report FDA Received Date: 10/22/2025
• Supplement Report FDA Received Date: 01/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/10/2017
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 71 YR
• Patient Sex: Female