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 Codes	Unspecified Infection (1930); Pocket Erosion (2013); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) and the right ventricular (rv) lead were electrically abandoned and a subcutaneous implantable cardioverter defibrillator (s-icd) system was implanted.No additional adverse patient effects were reported.
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) and the right ventricular (rv) lead were electrically abandoned and a subcutaneous implantable cardioverter defibrillator (s-icd) system was implanted.No additional adverse patient effects were reported.Additional information was received.This icd was explanted instead of electrically abandoned and received for analysis.Additional information was received.This icd system was explanted due to infection.
Additional Manufacturer Narrative
If pertinent information is provided in the future, a supplemental report will be submitted.This product investigation is still in progress.This report will be updated when product investigation is complete.
Additional Manufacturer Narrative
Additional information added to b5.F10 and h6 updated.This product investigation is still in progress.This report will be updated when product investigation is complete.

• 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: mark mishke ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(612)875-7234
• MDR Report Key: 50240149
• Report Number: 2124215-2026-43503
• Device Sequence Number: 21423928
• Product Code: LWS
• UDI-Device Identifier: 00802526588044
• UDI-Public: (01)00802526588044(17)260912
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P960040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2026

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: 09/12/2026
• Device Model Number: D432
• Device Catalogue Number: D432
• Device Lot Number: 345537
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/14/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/13/2026
• Supplement Report FDA Received Date: 09/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/01/2024
• 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: Required Intervention; Hospitalization
• Patient Age: 63 YR
• Patient Sex: Male