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

Model Number	D432
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/31/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this implantable cardioverter defibrillator (icd) had an infection.A revision was performed and the icd along with the right ventricular (rv) lead were explanted.No additional adverse patient effects were reported.The device was not returned for analysis.

• Brand Name: RESONATE? EL ICD VR
• 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 degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(651)582-6168
• MDR Report Key: 50287290
• Report Number: 2124215-2026-44065
• Device Sequence Number: 21256328
• Product Code: LWS
• UDI-Device Identifier: 00802526588044
• UDI-Public: (01)00802526588044(17)231029
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P960040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 08/17/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/29/2023
• Device Model Number: D432
• Device Catalogue Number: D432
• Device Lot Number: 291579
• 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: 07/31/2026
• Initial Report FDA Received Date: 08/17/2026
• Date Device Manufactured: 11/08/2021
• 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: Required Intervention; Hospitalization
• Patient Age: 41 YR
• Patient Sex: Male