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

Model Number G447

Device Problems Signal Artifact/Noise (1036); Over-Sensing (1438); Pacing Problem (1439); Failure to Read Input Signal (1581)

Patient Problem Asystole (4442)

Event Date 10/27/2023

Event Type  malfunction  

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) system exhibited noise oversensing and pacing inhibition for up to five seconds during non-sustained ventricular episodes.The noise was observed on the pace and sense right ventricular (rv) channel, but not on the shock channel.The patient attended the hospital and provocative maneuvers were performed, and only intermittent noise was observed on the shock channel, but further provocation revealed noisy signals on the rv pace-sense channel that were not oversensed.Low wave amplitude measurements were identified, so the device sensitivity was reprogrammed.X-ray imaging could not be performed during the patient's visit to the hospital.Technical services (ts) provided reprogramming recommendations.At this time, no further information is available.The device remains in service and no adverse patient effects have been reported.Additional information was received.Engineering confirmed that a stored event contains some non-cardiac signals over 1mv.It was discussed that in this situation further investigation, not excluding invasive approach, may be needed.The device remains in service.

• 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 ; 6515826168
• MDR Report Key: 18391990
• MDR Text Key: 331305240
• Report Number: 2124215-2023-73594
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P010012/S436
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/26/2023

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/13/2023
• Device Model Number: G447
• Device Catalogue Number: G447
• Device Lot Number: 265799
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2023
• Initial Date FDA Received: 12/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2021
• 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