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

Model Number	D533
Medical Device Problem Code	Defibrillation/Stimulation Problem (1573)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) did not deliver shock as therapy for a patients ventricular tachycardia (vt).The device settings were adjusted afterwards, with the therapy conditional zone lowered.Technical services (ts) was consulted and discussed how they should contact their physician to further discuss their device settings.This device remains in service.No adverse patient effects were reported.

• Brand Name: RESONATE? HF 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: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(651)582-6168
• MDR Report Key: 50243517
• Report Number: 2124215-2026-43547
• Device Sequence Number: 10267885
• Product Code: LWS
• UDI-Device Identifier: 00802526588310
• UDI-Public: (01)00802526588310(17)280324
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P960040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/13/2026

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 Model Number: D533
• Device Catalogue Number: D533
• Device Lot Number: 731015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2026
• Initial Report FDA Received Date: 08/13/2026
• Date Device Manufactured: 04/23/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 73 YR
• Patient Sex: Male