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

Model Number	D433
Medical Device Problem Code	Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Code	Shock from Patient Lead(s) (3162)
Date of Event	08/19/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the health care professional (hcp) requested a review of this implantable cardioverter defibrillator (icd), as it potentially delivered inappropriate therapy for an atrial tachycardia.Technical services (ts) reviewed the stored data and noted that the recorded ventricular episodes appeared consistent with atrial fibrillation (af) with rapid ventricular response (rvr) as the atrial rate was greater than the ventricular rate, and the rhythm appeared to be atrial-driven, with the shocks delivered the rhythm was successfully converted.The device appeared to be functioning as programmed; however, the therapy may have been inappropriate given the underlying atrial arrhythmia.No additional adverse patient effects were reported.This icd remains in service.

• Brand Name: RESONATE? EL ICD DR
• Common Device Name: Implantable Cardioverter Defibrillator (ICD)
• 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: 50691669
• Report Number: 2124215-2026-48136
• Device Sequence Number: 5915669
• Product Code: LWS
• UDI-Device Identifier: 00802526588075
• UDI-Public: (01)00802526588075(17)200529
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P960040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• 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: 05/29/2020
• Device Model Number: D433
• Device Catalogue Number: D433
• Device Lot Number: 547146
• 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: 08/19/2026
• Initial Report FDA Received Date: 09/09/2026
• Date Device Manufactured: 06/11/2018
• 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: 74 YR
• Patient Sex: Male