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

Model Number	D432
Medical Device Problem Codes	Signal Artifact/Noise (1036); Off-Label Use (1494); Under-Sensing (1661)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a follow up visit, the health care professional (hcp) called technical services (ts) for a consult review of this implantable cardioverter defibrillator (icd) presenting electrogram (egm).It was noted that the patient recently was implanted with a concomitant device and there appears to be some interaction noted.Upon review, the stored egms showed a ventricular arrhythmia was noted but the concomitant device pluses are only detecting every other beat.Due to device programming and the amplitude of the additional device pulses, every other vt beat is being intermittently undersensed.Ts provided programming optimization recommendations.No adverse patient effects were reported.This icd remains in service.

• Brand Name: RESONATE? EL ICD VR
• Common Device Name: Implantable Cardioverter Defibrillator (ICD)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): Boston Scientific Corporation; cashel road; clonmel CA 92672 ; EI 92672
• Manufacturer Contact: mark mischke ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(612)875-7234
• MDR Report Key: 25673573
• Report Number: 2124215-2026-34999
• Device Sequence Number: 18755194
• Product Code: LWS
• UDI-Device Identifier: 00802526588044
• UDI-Public: (01)00802526588044(17)231115
• 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
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2026

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: 11/15/2023
• Device Model Number: D432
• Device Catalogue Number: D432
• Device Lot Number: 292076
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2026
• Supplement Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 06/30/2026
• Supplement Report FDA Received Date: 09/08/2026
• Date Device Manufactured: 11/19/2021
• 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
• Patient Age: 59 YR
• Patient Sex: Female