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

Model Number	D533
Medical Device Problem Codes	Pacing Problem (1439); Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Code	Shock from Patient Lead(s) (3162)
Date of Event	07/07/2023
Type of Reportable Event	Serious Injury

• Brand Name: RESONATE? HF ICD DR
• 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 E91 T 862; EI E91 T862
• Manufacturer Contact: mark mishke ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(612)875-7234
• MDR Report Key: 50600898
• Report Number: 2124215-2026-45957
• Device Sequence Number: 13444871
• Product Code: LWS
• UDI-Device Identifier: 00802526588310
• UDI-Public: (01)00802526588310(17)250123
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/26/2026

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: 01/23/2025
• Device Model Number: D533
• Device Catalogue Number: D533
• Device Lot Number: 637638
• 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: Not provided
• Initial Report FDA Received Date: 09/04/2026
• Date Device Manufactured: 01/31/2023
• 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: 35 YR
• Patient Sex: Male