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

Model Number	G151
Medical Device Problem Codes	Premature Discharge of Battery (1057); Failure to Capture (1081); High Capture Threshold (3266)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) recorded a code 1003 battery voltage alert, indicating battery voltage too low for projected remaining capacity.Technical services (ts) evaluated the event and determined that the alert was a false positive, triggered by an abrupt increase in right ventricular (rv) pacing output to maximum settings due to loss of capture and high capture thresholds in a pacer-dependent patient.Ts explained that the increased power consumption resulted in a transient drop in battery voltage, accelerating the projected longevity to less than three months.Ts recommended continued monitoring as the device reached elective replacement indication (eri) battery status and device replacement was recommended.No adverse patient effects were reported.This crt-d remains in service.
Additional Manufacturer Narrative
Follow up report 1 (device evaluation): the complaint device was not returned to boston scientific; therefore, product analysis could not be performed.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 failure to capture 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.It can be concluded that unknown factors most probably contributed to the event.Conclusion code was updated to "no problem detected" was selected based on lack of objective evidence of a device defect/malfunction and passing product record reviews.
Event or Problem Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) recorded a code 1003 battery voltage alert, indicating battery voltage too low for projected remaining capacity.Technical services (ts) evaluated the event and determined that the alert was a false positive, triggered by an abrupt increase in right ventricular (rv) pacing output to maximum settings due to loss of capture and high capture thresholds in a pacer dependent patient.Ts explained that the increased power consumption resulted in a transient drop in battery voltage, accelerating the projected longevity to less than three months.Ts recommended continued monitoring as the device reached elective replacement indication (eri) battery status and device replacement was recommended.No adverse patient effects were reported.This crt-d remains in service.

• 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 ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 24218179
• Report Number: 2124215-2026-05333
• Device Sequence Number: 15769407
• Product Code: NIK
• UDI-Device Identifier: 00802526534638
• UDI-Public: (01)00802526534638(17)181122
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P010012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 05/08/2026

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: 11/22/2018
• Device Model Number: G151
• Device Catalogue Number: G151
• Device Lot Number: 119138
• 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: 01/12/2026
• Supplement Date Received by Manufacturer: 05/07/2026
• Initial Report FDA Received Date: 01/29/2026
• Supplement Report FDA Received Date: 05/08/2026
• Date Device Manufactured: 11/29/2016
• 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: 74 YR
• Patient Sex: Female