MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DYNAGEN? CRT-D; cardiac resynchronization therapy defibrillator (CRT-D)

Model Number	G150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the health care professional (hcp) called technical services (ts) regarding this cardiac resynchronization therapy defibrillator (crt-d) system.The hcp noted this crt-d had recently been explanted due to unknown reasons, however part of the lead was broken during the explant procedure and left behind.The hcp was asking ts about magnetic resonance imaging (mri).Ts discussed any fractured or broken lead would be non-conditional.No additional adverse patient effects were reported.This crt-d has not been returned for analysis.
Event or Problem Description
It was reported that the health care professional (hcp) called technical services (ts) regarding this cardiac resynchronization therapy defibrillator (crt-d) system.The hcp noted this crt-d had recently been explanted due to unknown reasons, however part of the lead was broken during the explant procedure and left behind.The hcp was asking ts about magnetic resonance imaging (mri).Ts discussed any fractured or broken lead would be non-conditional.No additional adverse patient effects were reported.This crt-d has not been returned for analysis.Additional information was received and it was reported that this crt-d was explanted due to a vegetation on the right ventricular (rv) lead.No additional adverse patient effects were reported.This crt-d has not been returned for analysis.
Additional Manufacturer Narrative
This product investigation is still in progress.This report will be updated when product investigation is complete.
Additional Manufacturer Narrative
This report is being submitted to update the information in section b5.This product investigation is still in progress.This report will be updated when product investigation is complete.

• 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 E91 T 862; EI E91 T862
• Manufacturer Contact: mark mischke ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(612)875-7234
• MDR Report Key: 50690740
• Report Number: 2124215-2026-48111
• Device Sequence Number: 5891720
• Product Code: NIK
• UDI-Device Identifier: 00802526534614
• UDI-Public: (01)00802526534614(17)240225
• 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: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2026

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: 02/25/2024
• Device Model Number: G150
• Device Catalogue Number: G150
• Device Lot Number: 508059
• 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: 08/21/2026
• Supplement Date Received by Manufacturer: 09/09/2026
• Initial Report FDA Received Date: 09/09/2026
• Supplement Report FDA Received Date: 09/10/2026
• Date Device Manufactured: 03/03/2022
• 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: 48 YR
• Patient Sex: Male