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

Model Number	D532
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Chest Pain (1776); Implant Pain (4561)
Date of Event	10/30/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this implantable cardioverter defibrillator (icd) went to the emergency room (er) for chest pain.The patient claimed the emergency medical technician (emt) said the electrocardiogram (ekg) showed he was having a heart attack, but the medical flight said the ekg didn't show that.The patient believed their chest pain was caused by gas but was told it could've been his device.The patient claimed they were not given results on latitude nxt.Technical services (ts) discussed that the clinician can access the latitude transmission and advised the patient to follow up.The patient also claimed they were feeling pain at the device site since implant that felt like a pinching sensation.The patient stated when they put their arms behind their back, the pain went away.The patient also claimed that the physician left behind gauze at implant, and the patient needed additional surgery to remove the gauze.Ts advised the patient to follow up with their physician for device and physician concerns.The patient stated they had a follow up with their primary clinician the day of the call.This icd remains in service.No adverse patient effects were reported.
Additional Manufacturer Narrative
This product investigation is still in progress.This report will be updated when product investigation is complete.

• Brand Name: RESONATE? HF 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 mischke ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(612)875-7234
• MDR Report Key: 50733661
• Report Number: 2124215-2026-48702
• Device Sequence Number: 10633557
• Product Code: LWS
• UDI-Device Identifier: 00802526588280
• UDI-Public: (01)00802526588280(17)270618
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/11/2026

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: D532
• Device Catalogue Number: D532
• Device Lot Number: 360895
• 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: 08/24/2026
• Initial Report FDA Received Date: 09/11/2026
• Date Device Manufactured: 06/26/2025
• 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
• Patient Age: 52 YR
• Patient Sex: Male