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

Model Number	D532
Medical Device Problem Code	Defibrillation/Stimulation Problem (1573)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that technical services (ts) was consulted for further review of this single chambered implantable cardioverter defibrillator (icd) stored ventricular episodes.Ts reviewed the stored ventricular episodes which showed patient was in an arrhythmia that lead to the device to deliver therapy.Ts is unable to determine if the therapy was appropriate or not and referred to the clinician for further evaluation.Subsequently, additional information from clinician received indicated that the patient was admitted to the hospital due to immediate reinitiation of vt and possibility of failed shocks.It was noted that patient was in a vt, the device delivered 6 shocks that were unsuccessful.Therapy was exhausted.The arrhythmia was terminated with medication and later on patient had a vt ablation.No additional adverse patient effects were reported.This icd remains in service.
Additional Manufacturer Narrative
If pertinent information is provided in the future, a supplemental report will be submitted.

• Brand Name: RESONATE? HF 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 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: 50570619
• Report Number: 2124215-2026-46083
• Device Sequence Number: 21307903
• Product Code: LWS
• UDI-Device Identifier: 00802526588280
• UDI-Public: (01)00802526588280(17)271118
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: P960040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 09/10/2026

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: 641007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/03/2026
• Supplement Date Received by Manufacturer: 09/01/2026
• Initial Report FDA Received Date: 09/02/2026
• Supplement Report FDA Received Date: 09/10/2026
• Date Device Manufactured: 12/02/2025
• 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: Hospitalization; Other
• Patient Age: 80 YR
• Patient Sex: Male