MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RESONATE HF CRT-D; Defibrillator, Automatic Implantable Cardioverter, With Crt-D

Model Number	G547
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Impaired Healing (2378); Fluid Discharge (2686); Swelling/ Edema (4577)
Date of Event	02/17/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) had exhibited serosanguinous drainage at the incision site, accompanied by minor swelling; no odor was present.A wound dressing was applied, and prophylactic antibiotic therapy was prescribed.No additional adverse patient effects were reported.This crt-d remains in service.

• Brand Name: RESONATE HF CRT-D
• Common Device Name: Defibrillator, Automatic Implantable Cardioverter, With Crt-D
• 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: 50601344
• Report Number: 2124215-2026-47005
• Device Sequence Number: 13439432
• Product Code: NIK
• UDI-Device Identifier: 00802526589744
• UDI-Public: (01)00802526589744(17)271205
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P010012
• 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: Physician
• Type of Report: Initial

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: G547
• Device Catalogue Number: G547
• Device Lot Number: 380230
• 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: 12/16/2025
• 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; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male