MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RESONATE HF CRT-D; CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR

Model Number G547

Device Problems Pacing Problem (1439); Inappropriate/Inadequate Shock/Stimulation (1574); Inaccurate Synchronization (1609); Under-Sensing (1661)

Patient Problems Atrial Fibrillation (1729); Electric Shock (2554)

Event Date 11/20/2023

Event Type  Injury  

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) delivered inappropriate anti-tachycardia pacing (atp) and electric shocks due to atrial fibrillation (af).Boston scientific technical services (ts) discussed how four conducted beats after the atp sequence was given, the patient went into a brief nonsustained ventricular tachycardia (nsvt) and then returned to 1:1 conduction in the vt zone.The first 41j shock was given and put the patient into af and increased the heart rate.Additionally, undersensing of af was observed by ts.No additional adverse patient effects were reported.At this time, this device remains in service.

• Brand Name: RESONATE HF CRT-D
• Type of Device: CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 18231168
• MDR Text Key: 329281328
• Report Number: 2124215-2023-67539
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526589744
• UDI-Public: 00802526589744
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: G547
• Device Catalogue Number: G547
• Device Lot Number: 308098
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 49 YR
• Patient Sex: Male