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

Model Number	D433
Medical Device Problem Codes	Failure to Capture (1081); High impedance (1291); Over-Sensing (1438)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) exhibited high out of range impedance measurements and a signal artifact monitoring (sam) episode due to artifact related to the minute ventilation (mv) feature signal on its right atrial (ra) lead.Additionally, there was loss of capture (loc) for its ra lead following the sam episode.Technical services (ts) was consulted and discussed stored data.The device will have its programming adjusted and the patient will continue to be monitored.This device remains in service.No adverse patient effects were reported.
Additional Manufacturer Narrative
A good faith effort was performed to obtain additional information.At this time, no further information is available.Should additional information become available this report will be updated.

• Brand Name: RESONATE? EL 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: mark mischke ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(612)875-7234
• MDR Report Key: 50933500
• Report Number: 2124215-2026-51691
• Device Sequence Number: 18564205
• Product Code: LWS
• UDI-Device Identifier: 00802526588075
• UDI-Public: (01)00802526588075(17)240927
• 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: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/27/2024
• Device Model Number: D433
• Device Catalogue Number: D433
• Device Lot Number: 630720
• 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: 09/09/2026
• Initial Report FDA Received Date: 09/29/2026
• Date Device Manufactured: 10/06/2022
• 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
• Patient Age: 68 YR
• Patient Sex: Male