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); Failure to Read Input Signal (1581); High Capture Threshold (3266)

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

Event Date 12/13/2020

Event Type  malfunction  

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) system recorded noise in the left ventricular (lv) egm.Data analysis was performed, there were variable intrinsic amplitude values, the lv pacing impedance measurement was out of range, measuring greater than 3000 ohms and loss of capture was observed in the lv.Noise was also observed in the rv egm and there were changes in the shock egm morphology.Technical services recommended troubleshooting steps to exclude mechanical issues and lead impairment.Additionally, device was reprogrammed.No adverse patient effects were reported.This device, competitor lv and competitor rv lead remain in-service.Additional information was provided, it was reported that the patient was seen for a follow-up visit.Troubleshooting steps were performed and could not reproduce noise.Shifted vector from lv ring 1 to lv ring 2 to lv ring 3 to lv ring and identified high thresholds, and noise when using lv ring 2.The device was reprogrammed, and no adverse patient effects were reported.This device, competitor lv and competitor rv lead remain in-service.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) system recorded noise in the left ventricular (lv) egm.Data analysis was performed, there were variable intrinsic amplitude values, the lv pacing impedance measurement was out of range, measuring greater than 3000 ohms and loss of capture was observed in the lv.Noise was also observed in the rv egm and there were changes in the shock egm morphology.Technical services recommended troubleshooting steps to exclude mechanical issues and lead impairment.Additionally, device was reprogrammed.No adverse patient effects were reported.This device, competitor lv and competitor rv lead remain in-service.Additional information was provided, it was reported that the patient was seen for a follow-up visit.Troubleshooting steps were performed and could not reproduce noise.Shifted vector from lv ring 1 to lv ring 2 to lv ring 3 to lv ring and identified high thresholds, and noise when using lv ring 2.The device was reprogrammed, and no adverse patient effects were reported.This device, competitor lv and competitor rv lead remain in-service.

Manufacturer Narrative

This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.The associated investigation determined that this device exhibited intermittent impedance measurements with no conclusive evidence of a product performance issue or inadequate lead-to-device connection.Engineering analysis and testing of returned products identified that any repeated, small movements of the lead terminal ring can create wearing of the lead terminal ring and generate microscopic particles, which may accumulate and oxidize over time.This can impact the connection between the spring contact and the lead ring, resulting in intermittent changes in impedance measurements.

• 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: 17803589
• MDR Text Key: 324125157
• Report Number: 2124215-2023-52129
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/13/2023

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: 01/08/2021
• Device Model Number: G447
• Device Catalogue Number: G447
• Device Lot Number: 207298
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/04/2023
• Initial Date FDA Received: 09/22/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/23/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 76 YR