MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DYNAGEN? EL ICD DR; Implantable Cardioverter Defibrillator

Model Number	D153
Medical Device Problem Codes	Defibrillation/Stimulation Problem (1573); Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Code	Tachycardia (2095)
Date of Event	05/31/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This product investigation is still in progress.This report will be updated when product investigation is complete.If pertinent information is provided in the future, a supplemental report will be submitted.
Event or Problem Description
It was reported that while this implantable cardioverter defibrillator (icd) was delivering anti-tachycardia pacing (atp) for ventricular fibrillation, an inappropriate shock was delivered that accelerated the rhythm into a short burst of ventricular tachycardia (vt).Technical services (ts) was consulted to review episodes and confirmed the initial condition was patient related and that atp was highly successful.Ts noted the patient received one inappropriate shock after atp had converted, creating the short burst of vt.Ts determined that therapy was never exhausted and gave system and patient related recommendations based on the episodes reviewed.
Event or Problem Description
It was reported that while this implantable cardioverter defibrillator (icd) was delivering anti-tachycardia pacing (atp) for ventricular fibrillation, an inappropriate shock was delivered that accelerated the rhythm into a short burst of ventricular tachycardia (vt).Technical services (ts) was consulted to review episodes and confirmed the initial condition was patient related and that atp was highly successful.Ts noted the patient received one inappropriate shock after atp had converted, creating the short burst of vt.Ts determined that therapy was never exhausted and gave system and patient related recommendations based on the episodes reviewed.
Additional Manufacturer Narrative
The device was not returned for analysis; therefore, a technical 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 rhythm acceleration 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.A similar complaint review was completed using global similar complaint review tool, which reviewed as reported device code 2278: rhythm acceleration and did not identify any emerging trends or similar complaints that require escalation.However a review for the as reported impact code f1009: inappropriate treatment identified that this was a new code introduced in feb 2026 increased trend was the result of the usage and implementation of this code by cmc, which does not represent a change in product performance.No escalation is required.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of no problem detected.

• Brand Name: DYNAGEN? EL ICD DR
• Common Device Name: Implantable Cardioverter 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: mark mischke ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(612)875-7234
• MDR Report Key: 25610817
• Report Number: 2124215-2026-33574
• Device Sequence Number: 9942172
• Product Code: LWS
• UDI-Device Identifier: 00802526534829
• UDI-Public: (01)00802526534829(17)180913
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P960040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2026

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: 09/13/2018
• Device Model Number: D153
• Device Catalogue Number: D153
• Device Lot Number: 205925
• Was Device Available for Evaluation?: No
• 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: 06/01/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/24/2026
• Supplement Report FDA Received Date: 09/04/2026
• Date Device Manufactured: 11/23/2016
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 77 YR
• Patient Sex: Male