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

Model Number G447

Device Problems Device Alarm System (1012); Signal Artifact/Noise (1036); Failure to Capture (1081); Failure to Read Input Signal (1581); Low impedance (2285); High Capture Threshold (3266)

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

Event Date 12/03/2023

Event Type  malfunction  

Event Description

It was reported that the patient with this recently implanted cardiac resynchronization therapy defibrillator (crt-d) contacted boston scientific technical services (ts) indicating that they heard beeping tones after the implant procedure.Ts reviewed data from the device and did not find any abnormalities that could have triggered beeping tones, but it was observed that high left ventricular (lv) pacing threshold measurements and lv loss of capture on the presenting electrograms (egm) were present.Further investigation also found that the left ventricular autothreshold (lvat) was greater than the programmed amplitude or suspended, and the same observation for the right atrial autothreshold (raat), but in this case, it was due to noise or low evoked response (er) as this is a recent implant.Ts recommended an in-office visit to verify lv lead location via x-ray imaging and to evaluate if there are other lv configurations with better pacing performance.A commanded raat was also recommended to re-evaluate the right atrial (ra) automatic threshold measurement, and a manual ra threshold to verify lead performance.At this time, no further information is available.No adverse patient effects were reported.The device remains in service.

Event Description

It was reported that the patient with this recently implanted cardiac resynchronization therapy defibrillator (crt-d) contacted boston scientific technical services (ts) indicating that they heard beeping tones after the implant procedure.Ts reviewed data from the device and did not find any abnormalities that could have triggered beeping tones, but it was observed that high left ventricular (lv) pacing threshold measurements and lv loss of capture on the presenting electrograms (egm) were present.Further investigation also found that the left ventricular autothreshold (lvat) was greater than the programmed amplitude or suspended, and the same observation for the right atrial autothreshold (raat), but in this case, it was due to noise or low evoked response (er) as this is a recent implant.Ts recommended an in-office visit to verify lv lead location via x-ray imaging and to evaluate if there are other lv configurations with better pacing performance.A commanded raat was also recommended to re-evaluate the right atrial (ra) automatic threshold measurement, and a manual ra threshold to verify lead performance.At this time, no further information is available.No adverse patient effects were reported.The device remains in service.The cause of the reported observations is still unknown at this time.Evidence suggests that this 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: 18406563
• MDR Text Key: 331504878
• Report Number: 2124215-2023-74102
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P010012/S436
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/15/2024

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 Model Number: G447
• Device Catalogue Number: G447
• Device Lot Number: 319731
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/11/2023
• Initial Date FDA Received: 12/27/2023
• Supplement Dates Manufacturer Received: 01/15/2024
• Supplement Dates FDA Received: 01/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2023
• 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