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

Model Number G447

Device Problems Signal Artifact/Noise (1036); Failure to Capture (1081); High impedance (1291); Over-Sensing (1438); Failure to Read Input Signal (1581)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/29/2024

Event Type  malfunction  

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) and right atrial (ra) lead exhibited oversensing of noise and out-of-range pacing impedance measurements greater than 2,000 ohms resulting in a signal artifact monitor (sam) episode, and deactivation of the minute ventilation (mv) feature.Additionally, possible ra loss of capture (loc) was noted and the right atrial automatic threshold (raat) test entered suspension due to a low evoked response.The patient had an intrinsic rhythm at the time of the possible loc.Technical services (ts) recommended further review to the clinic.A health care professional (hcp) noted the patient was scheduled to be seen in clinic.No adverse patient effects were reported.This device remains in service.Additional information has been requested.If information is provided in the future, a supplemental report will be issued.Additional information was received that the patient was seen in clinic.An ra lead fracture was suspected to be the root cause of the reported observations.It was noted that the patient had been active and performing activities involving lifting arms above the head.The device was reprogrammed to vdd, ra automatic threshold tests were programmed off and sensitivity programming changes were made on the atrial channel to reduce the likelihood of tracking any noise.Monitoring will be continued at this time.No adverse patient effects were reported.This device remains in service.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: 18882386
• MDR Text Key: 337420795
• Report Number: 2124215-2024-14739
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P010012/S436
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/11/2024

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: 12/09/2023
• Device Model Number: G447
• Device Catalogue Number: G447
• Device Lot Number: 274078
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1