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

Model Number	D433
Medical Device Problem Codes	Pacing Problem (1439); Under-Sensing (1661)
Health Effect - Clinical Code	Shock from Patient Lead(s) (3162)
Date of Event	06/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) delivered nine bursts of anti-tachycardia pacing (atp) as inappropriate therapy due to undersensing of the patients atrial flutter (af).Technical services (ts) was consulted and reviewed stored data.Ts discussed available programming options based on the patients rhythm.This device remains in serv ice.No adverse patient effects were reported.

• Brand Name: RESONATE? 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 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: 50423822
• Report Number: 2124215-2026-45531
• Device Sequence Number: 16056790
• Product Code: LWS
• UDI-Device Identifier: 00802526588075
• UDI-Public: (01)00802526588075(17)270717
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: P960040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/24/2026

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 Model Number: D433
• Device Catalogue Number: D433
• Device Lot Number: 710085
• 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: 08/13/2026
• Initial Report FDA Received Date: 08/25/2026
• Date Device Manufactured: 07/29/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Sex: Unknown