MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RESONATE HF ICD DR; Implantable cardioverter defibrillator

Model Number	D533
Medical Device Problem Code	Signal Artifact/Noise (1036)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) recorded ventricular episodes presented in the logbook.The boston scientific technical services consultant noted noisy signals on both channel which was suspected to be electromagnetic interference and recommended to confirm if the patient had any procedures or surgery performed.As of this time, this icd remains in service.No adverse patient effects were reported.Additional information indicated that the noisy signals were from the cauterization when the patient was having a surgery.There was no reprogramming performed.Subsequently, this icd was explanted and replaced with a different model.No additional 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: 50228408
• Report Number: 2124215-2026-43334
• Device Sequence Number: 10256619
• Product Code: LWS
• UDI-Device Identifier: 00802526588310
• UDI-Public: (01)00802526588310(17)260621
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P960040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/12/2026

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: 06/21/2026
• Device Model Number: D533
• Device Catalogue Number: D533
• Device Lot Number: 679001
• 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: 07/30/2026
• Initial Report FDA Received Date: 08/12/2026
• Date Device Manufactured: 07/11/2024
• 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: Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male