MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RESONATE X4 CRT-D; IMPLANTABLE DEVICE

Model Number G447

Device Problems Signal Artifact/Noise (1036); Failure to Capture (1081); Low impedance (2285); Device Sensing Problem (2917)

Patient Problems Hematoma (1884); Syncope/Fainting (4411)

Event Date 03/03/2024

Event Type  Injury  

Event Description

It was reported that a few days after implant of the cardiac resynchronization therapy defibrillator (crt-d) system, the left ventricular (lv) pace impedance was less than 200 ohms and there was loss of capture in certain programming configurations.The impedance measurement the day prior was 440 ohms.Some noise was observed when measuring impedance and the lv threshold was highly variable.Engineering reviewed the device data and determined there was an issue with the lv pacing channel of the crt-d device and immediate device replacement was recommended.The patient had experienced syncope and was re-admitted to the hospital.It was noted that the patient had upcoming chemotherapy appointments and there was also a large hematoma over the device implant site.The device was subsequently replaced and is expected to be returned for analysis.No additional adverse patient effects were reported.

Event Description

It was reported that a few days after implant of the cardiac resynchronization therapy defibrillator (crt-d) system, the left ventricular (lv) pace impedance was less than 200 ohms and there was loss of capture in certain programming configurations.The impedance measurement the day prior was 440 ohms.Some noise was observed when measuring impedance and the lv threshold was highly variable.Engineering reviewed the device data and determined there was an issue with the lv pacing channel of the crt-d device and immediate device replacement was recommended.The patient had experienced syncope and was re-admitted to the hospital.It was noted that the patient had upcoming chemotherapy appointments and there was also a large hematoma over the device implant site.The device was subsequently replaced and is expected to be returned for analysis.No additional adverse patient effects were reported.It was additionally reported that the pocket hematoma was drained during the device replacement procedure.The lv lead was tested in both bipolar and unipolar configurations and capture was confirmed, and impedances were stable.The lv lead remains in service.

• Brand Name: RESONATE X4 CRT-D
• Type of Device: IMPLANTABLE DEVICE
• 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: 18876988
• MDR Text Key: 337348877
• Report Number: 2124215-2024-14616
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2024
• 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: 310378
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2023
• 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): Hospitalization; Required Intervention
• Patient Age: 73 YR