MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DYNAGEN? EL ICD DR; Implantable Cardioverter Defibrillator (Non-Crt)

Model Number	D152
Medical Device Problem Codes	Over-Sensing (1438); Pacing Problem (1439); Failure to Convert Rhythm (1540); Defibrillation/Stimulation Problem (1573); Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Codes	Ventricular Fibrillation (2130); Shock from Patient Lead(s) (3162)
Date of Event	07/23/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) delivered inappropriate anti-tachycardia pacing (atp) and five electric shocks due to sinus tachycardia.The rate started with a 1:1 rhythm with a high rhythm id (rid) match, then rid became negative which led to the inappropriate therapy.The atp accelerated the ventricular tachycardia (vt) into the ventricular fibrillation (vf) zone.The rhythm went from vf to vt several times during the five shocks.Therapy was exhausted and didn't convert the arrythmia.Also, it was noted there was intermittent atrial oversensing of ventricular signals.Technical services (ts) recommended reprogramming options.This icd remains in service.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
This product investigation is still in progress.This report will be updated when product investigation is complete.
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) delivered inappropriate anti-tachycardia pacing (atp) and five electric shocks due to sinus tachycardia.The rate started with a 1:1 rhythm with a high rhythm id (rid) match, then rid became negative which led to the inappropriate therapy.The atp accelerated the ventricular tachycardia (vt) into the ventricular fibrillation (vf) zone.The rhythm went from vf to vt several times during the five shocks.Therapy was exhausted and didn't convert the arrythmia.Also, it was noted there was intermittent atrial oversensing of ventricular signals.Technical services (ts) recommended reprogramming options.This icd remains in service.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
This product investigation is still in progress.This report will be updated when product investigation is complete.This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.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.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 (Non-Crt)
• 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: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(651)582-6168
• MDR Report Key: 50133105
• Report Number: 2124215-2026-41772
• Device Sequence Number: 5675159
• Product Code: LWS
• UDI-Device Identifier: 00802526534324
• UDI-Public: (01)00802526534324(17)260403
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: P960040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/04/2026

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: 04/03/2026
• Device Model Number: D152
• Device Catalogue Number: D152
• Device Lot Number: 671920
• 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: 07/23/2026
• Initial Report FDA Received Date: 08/04/2026
• Date Device Manufactured: 04/12/2024
• 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: Life Threatening; Hospitalization
• Patient Age: 55 YR
• Patient Sex: Male