MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RESONATE EL ICD VR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number	D432
Medical Device Problem Codes	Over-Sensing (1438); Failure to Read Input Signal (1581)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This product investigation is still in progress.This report will be updated when product investigation is complete.
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) stored a non-sustained ventricular tachycardia (nsvt) due to oversensing of wide complexes.The patient appeared to be in a slow ventricular tachycardia (vt) with a rate in the 100 to 110 beats per minute (bpm) range.The shock channel showed wide complexes, and presenting strips appeared narrow and upright.A monitor zone was programmed to 110 bpm for continued monitoring to determine whether this behavior was a common occurrence.The physician planned to bring the patient in for an office visit at a later date for furhter evaluation.This icd remains in service.No adverse patient effects were reported.

• 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 ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 25038794
• Report Number: 2124215-2026-23370
• Device Sequence Number: 13354607
• Product Code: LWS
• UDI-Device Identifier: 00802526588044
• UDI-Public: (01)00802526588044(17)241121
• 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: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/30/2026

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: 11/21/2024
• Device Model Number: D432
• Device Catalogue Number: D432
• Device Lot Number: 309131
• 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: 04/09/2026
• Initial Report FDA Received Date: 04/30/2026
• Date Device Manufactured: 11/29/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 31 YR
• Patient Sex: Female