MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RESONATE X4 CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D

Model Number G447

Device Problems Over-Sensing (1438); Pacing Problem (1439); Inappropriate/Inadequate Shock/Stimulation (1574); Unexpected Therapeutic Results (1631); Use of Device Problem (1670)

Patient Problem Shock from Patient Lead(s) (3162)

Event Date 02/21/2024

Event Type  malfunction  

Manufacturer Narrative

If pertinent information is provided in the future, a supplemental report will be submitted.

Event Description

It was reported that following the successful implant of this cardiac resynchronization therapy defibrillator (crt-d) system, patient went into supraventricular tachycardia (svt) then atrial fibrillation (af) with rapid ventricular response (rvr) the following day.Over the course of four episodes, there were four bursts of anti-tachycardia pacing (atp) plus a single shock delivered, and the shock converted the patient's rhythm.It was noted that the patient had no prior history of af.Additionally, a stored atrial tachy response (atr) episode from the day after implant showed farfield oversensing.Technical services (ts) reviewed troubleshooting options and programming considerations.This crt-d remains in service.No additional adverse patient effects were reported.

Event Description

It was reported that following the successful implant of this cardiac resynchronization therapy defibrillator (crt-d) system, patient went into supraventricular tachycardia (svt) then atrial fibrillation (af) with rapid ventricular response (rvr) the following day.Over the course of four episodes, there were four bursts of anti-tachycardia pacing (atp) plus a single shock delivered, and the shock converted the patient's rhythm.It was noted that the patient had no prior history of af.Additionally, a stored atrial tachy response (atr) episode from the day after implant showed farfield oversensing.Technical services (ts) reviewed troubleshooting options and programming considerations.This crt-d remains in service.No additional adverse patient effects were reported.Additional information received reported that there was a recommended option for this cardiac resynchronization therapy defibrillator (crt-d) to create a rhythm id template at implant, rather than waiting for the device to create templates every two hours.While it is not certain whether creating this template at implant would have inhibited the previously reported inappropriate tachy therapy, it cannot be ruled out.This crt-d remains in service.No additional adverse patient effects were reported.

Manufacturer Narrative

If pertinent information is provided in the future, a supplemental report will be submitted.

• Brand Name: RESONATE X4 CRT-D
• Type of Device: 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 ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 18894471
• MDR Text Key: 337551063
• Report Number: 2124215-2024-15197
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526589539
• UDI-Public: 00802526589539
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G447
• Device Catalogue Number: G447
• Device Lot Number: 318802
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/03/2023
• 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 Age: 74 YR
• Patient Sex: Female