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

Model Number	D533
Medical Device Problem Codes	Failure to Convert Rhythm (1540); Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Code	Shock from Patient Lead(s) (3162)
Date of Event	06/30/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this implantable cardioverter defibrillator (icd) experienced ventricular tachycardia (vt) for which the implanted defibrillator delivered six appropriate shocks; however, the arrhythmia was not terminated by device therapy.The patient reported that intravenous amiodarone was subsequently administered, resulting in successful conversion of the arrhythmia.Additional information indicated that post-event defibrillation threshold (dft) testing demonstrated successful conversion with the first shock.The patient contacted technical services (ts) to inquire why the delivered therapies were unsuccessful and was advised that multiple factors may influence therapy efficacy.The patient was referred for further evaluation.No additional adverse patient effects were reported.This icd remains in service.
Event or Problem Description
It was reported that the patient with this implantable cardioverter defibrillator (icd) experienced ventricular tachycardia (vt) for which the implanted defibrillator delivered six appropriate shocks; however, the arrhythmia was not terminated by device therapy.The patient reported that intravenous amiodarone was subsequently administered, resulting in successful conversion of the arrhythmia.Additional information indicated that post-event defibrillation threshold (dft) testing demonstrated successful conversion with the first shock.The patient contacted technical services (ts) to inquire why the delivered therapies were unsuccessful and was advised that multiple factors may influence therapy efficacy.The patient was referred for further evaluation.No additional adverse patient effects were reported.This icd remains in service.
Additional Manufacturer Narrative
This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.A review of the device history record (dhr) was performed.The review of the dhr identified that there were no process related non-conformances, scrap, or rework performed during the production that could explain the event.The reviews ensure each device meets specification prior to release for use.There is no indication the device manufacturing process contributed to the reported complaint.A risk review was completed and confirmed that the event of difficulty converting rhythm (ambulatory) was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Review of labeling determined that the complaint situation was listed in the manual.There was no indication in the complaint that the product was not used in accordance to labeling.The manual was unlikely to be the cause of the reported complaint; translation, wording, or graphics does not require further review.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code cause not established.

• Brand Name: RESONATE? HF ICD DR
• 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 E91 T 862; EI E91 T862
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(651)582-6168
• MDR Report Key: 50244666
• Report Number: 2124215-2026-43575
• Device Sequence Number: 10378437
• Product Code: LWS
• UDI-Device Identifier: 00802526588310
• UDI-Public: (01)00802526588310(17)260812
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P960040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/13/2026

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: 08/12/2026
• Device Model Number: D533
• Device Catalogue Number: D533
• Device Lot Number: 682683
• 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: 07/24/2026
• Initial Report FDA Received Date: 08/13/2026
• Date Device Manufactured: 08/29/2024
• 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: Other
• Patient Age: 76 YR
• Patient Sex: Male