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

Model Number	G154
Medical Device Problem Codes	Pacing Problem (1439); Incorrect, Inadequate or Imprecise Result or Readings (1535); Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Codes	Shock from Patient Lead(s) (3162); Presyncope (4410); Asystole (4442)
Date of Event	11/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) presented to the emergency room due to pauses in pacing greater than two seconds and numerous inappropriate shocks.The patient had symptoms of presyncope.It was then determined that this crt-d was in safety mode.Technical services (ts) recommended device replacement.Subsequently, the device was explanted and replaced.At this time, no additional adverse patient effects have been reported, and this crt-d has not been returned for analysis.
Additional Manufacturer Narrative
If pertinent information is provided in the future, a supplemental report will be submitted.
Additional Manufacturer Narrative
A review of the device history record (dhr) was performed.The review of the dhr identified that there were no process related non-conformances, scrap, or rework performed during the production that could explain the event.The reviews ensure each device meets specification prior to release for use.There is no indication the device manufacturing process contributed to the reported complaint.A risk review was completed and confirmed that the event of device displays error message was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Review of labeling determined that the complaint situation was listed in the manual.There was no indication in the complaint that the product was not used in accordance to labeling.The manual was unlikely to be the cause of the reported complaint; translation, wording, or graphics does not require further review.The device was not returned for analysis; therefore, a technical analysis could not be performed.Good faith effort attempts were made to try and retrieve the device; however, the facility retained the device.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of no problem detected.If pertinent information is provided in the future, a supplemental report will be submitted.
Event or Problem Description
It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) presented to the emergency room due to pauses in pacing greater than two seconds and numerous inappropriate shocks.The patient had symptoms of presyncope.It was then determined that this crt-d was in safety mode.Technical services (ts) recommended device replacement.Subsequently, the device was explanted and replaced.At this time, no additional adverse patient effects have been reported, and this crt-d has not been returned for analysis.
Event or Problem Description
It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) presented to the emergency room due to pauses in pacing greater than two seconds and numerous inappropriate shocks.The patient had symptoms of presyncope.It was then determined that this crt-d was in safety mode.Technical services (ts) recommended device replacement.Subsequently, the device was explanted and replaced.At this time, no additional adverse patient effects have been reported, and this crt-d has been returned for analysis.
Additional Manufacturer Narrative
This report is being submitted as a correction was made to the impact codes.The code inappropriate treatment was added.Additionally, this device was received for analysis.This product investigation is still in progress.This report will be updated when product investigation is complete.A review of the device history record (dhr) was performed.The review of the dhr identified that there were no process related non-conformances, scrap, or rework performed during the production that could explain the event.The reviews ensure each device meets specification prior to release for use.There is no indication the device manufacturing process contributed to the reported complaint.A risk review was completed and confirmed that the event of device displays error message was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Review of labeling determined that the complaint situation was listed in the manual.There was no indication in the complaint that the product was not used in accordance to labeling.The manual was unlikely to be the cause of the reported complaint; translation, wording, or graphics does not require further review.The device was not returned for analysis; therefore, a technical analysis could not be performed.Good faith effort attempts were made to try and retrieve the device; however, the facility retained the device.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of no problem detected.If pertinent information is provided in the future, a supplemental report will be submitted.

• 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: 23582810
• Report Number: 2124215-2025-84086
• Device Sequence Number: 15835993
• Product Code: NIK
• 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: 2021
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/28/2026

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: 07/30/2021
• Device Model Number: G154
• Device Catalogue Number: G154
• Device Lot Number: 104374
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2025
• Supplement Date Received by Manufacturer: 04/08/2026; 05/28/2026
• Initial Report FDA Received Date: 11/18/2025
• Supplement Report FDA Received Date: 04/09/2026; 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/28/2019
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Other
• Patient Sex: Male