MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RESONATE X4 CRT-D; CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D)

Model Number G447

Device Problems Inaccurate Synchronization (1609); Telemetry Discrepancy (1629)

Patient Problem Ventricular Fibrillation (2130)

Event Date 03/01/2024

Event Type  Injury  

Event Description

It was reported that the health care professional (hcp) had trouble interrogating this cardiac resynchronization therapy defibrillator (crt-d) with the consult.Technical services (ts) assisted the hcp with interrogating the device and was successful.The hcp asked ts to review the reports.Ts reviewed the reports and noted several episodes where the patient's ventricular tachycardia (vt) would not provide therapy as the vt was below the vt zone.Another episode showed an anti-tachycardia pacing (atp) and shock therapy was delivered, however, the rhythm accelerated into ventricular fibrillation (vf).Another shock was delivered, and the rhythm converted.Ts advised the hcp to follow up with cardiology for the multiple vt episodes.The device remains in use.No additional adverse patient effects were reported.

• Brand Name: RESONATE X4 CRT-D
• Type of Device: CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (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 55112-5798 ; 6515826168
• MDR Report Key: 18906939
• MDR Text Key: 337697938
• Report Number: 2124215-2024-15622
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: G447
• Device Catalogue Number: G447
• Device Lot Number: 308750
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2023
• 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): Life Threatening
• Patient Age: 67 YR
• Patient Sex: Male