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	High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) and the non-boston scientific right ventricular (rv) lead exhibited a high out of range shock impedance measurement, greater than 200 ohms.Technical services (ts) discussed that the measurement was stable in the 40-50 ohm range until the out of range measurement.There was no evidence of lead noise.Ts recommended further in clinic evaluation.This crt-d remains in service.No adverse patient effects were reported.
Additional Manufacturer Narrative
This product investigation is still in progress.This report will be updated when product investigation is complete.

• 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: 50917569
• Report Number: 2124215-2026-51456
• Device Sequence Number: 5394112
• Product Code: NIK
• UDI-Device Identifier: 00802526589744
• UDI-Public: (01)00802526589744(17)250820
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: P010012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

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: 08/20/2025
• Device Model Number: G547
• Device Catalogue Number: G547
• Device Lot Number: 316602
• 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: 09/14/2026
• Initial Report FDA Received Date: 09/28/2026
• Date Device Manufactured: 08/29/2023
• 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
• Patient Sex: Female