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

Model Number G447

Device Problems Premature Discharge of Battery (1057); Low impedance (2285); High Capture Threshold (3266)

Patient Problem Anxiety (2328)

Event Date 11/17/2023

Event Type  malfunction  

Event Description

It was reported that the battery of this implantable cardioverter defibrillator (icd) was suspected to be depleting prematurely.Additionally, this system exhibited low out of range left ventricular (lv) pacing impedance of less than 200 ohms.Lead insulation damage is suspected to be the cause of this observation, but this has not been conclusively determined.A request was made to have data from this device analyzed, but the results are not available at this time.The patient reported to have anxiety, but no additional adverse effects.The device remains in service.Additional information was received.Data analysis was performed, and it was found that this device is depleting normally and there is no evidence of premature battery depletion.It appears that the lv output was set to 7.5 v, so ts explained that it is important to assess lead integrity as insulation damage is suspected.As this is a recently implanted system, ts also recommended focusing on the device and lead connection to exclude any potential under insertion which may affect electrical parameters.A troubleshooting guide was provided to understand options to ensure pacing capture and proper brady support, which includes a guide to search for noise, patient maneuvers, x-ray imaging and device reprogramming.No adverse patient effects were reported.The device remains in service.Additional information was received.The patient was evaluated, and the physician has made the decision to perform a revision or replacement of the system.At this time, there is no evidence that suggests that this intervention has been performed.No adverse patient effects were reported.The device remains in service.

Event Description

It was reported that the battery of this implantable cardioverter defibrillator (icd) was suspected to be depleting prematurely.Additionally, this system exhibited low out of range left ventricular (lv) pacing impedance of less than 200 ohms.Lead insulation damage is suspected to be the cause of this observation, but this has not been conclusively determined.A request was made to have data from this device analyzed, but the results are not available at this time.The patient reported to have anxiety, but no additional adverse effects.The device remains in service.Additional information was received.Data analysis was performed, and it was found that this device is depleting normally and there is no evidence of premature battery depletion.It appears that the lv output was set to 7.5 v, so ts explained that it is important to assess lead integrity as insulation damage is suspected.As this is a recently implanted system, ts also recommended focusing on the device and lead connection to exclude any potential under insertion which may affect electrical parameters.A troubleshooting guide was provided to understand options to ensure pacing capture and proper brady support, which includes a guide to search for noise, patient maneuvers, x-ray imaging and device reprogramming.No adverse patient effects were reported.The device remains in service.Additional information was received.The patient was evaluated, and the physician has made the decision to perform a revision or replacement of the system.At this time, there is no evidence that suggests that this intervention has been performed.No adverse patient effects were reported.The device remains in service.Additional information was received.The physician made the decision to reprogram the device to right ventricular (rv) pacing only and as a result, an increase in the estimated remaining battery longevity was observed.An lv lead insulation damage is suspected to be the cause of the reported impedance observations.An invasive system revision was not necessary.The patient will continue to be monitored and no adverse patient effects have been reported.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: 18282120
• MDR Text Key: 329934968
• Report Number: 2124215-2023-69454
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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,Followup
• Report Date: 12/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2023
• 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: 311320
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2023
• 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