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

Model Number G247

Device Problems Over-Sensing (1438); Pacing Problem (1439)

Patient Problem Bradycardia (1751)

Event Date 12/26/2023

Event Type  malfunction  

Event Description

It was reported that the device clinic treating health care professional (hcp) called technical services (ts) for further review of the pacemaker presenting electrogram (egm).Upon review, far field oversensing of intrinsic right atrial (ra) signals on the left ventricular (lv) lead which lead to pacing inhibition on the lv lead were observed.Ts also observed records of unsuccessful right ventricular auto threshold (rvat) tests.Ts discussed possible causes with the hcp.At this time, the crtd device remains in service.

Event Description

It was reported that the device clinic treating health care professional (hcp) called technical services (ts) for further review of the pacemaker presenting electrogram (egm).Upon review, far field oversensing of intrinsic right atrial (ra) signals on the left ventricular (lv) lead which lead to pacing inhibition on the lv lead were observed.Ts also observed records of unsuccessful right ventricular auto threshold (rvat) tests.Ts discussed possible causes with the hcp.At this time, the crtd device remains in service.Additional information was provided by the local field representative that reported the left ventricular (lv) lead exhibited high pacing thresholds in addition to the observed oversensing and pacing inhibition.The field representative noted that the patient reported having visited the emergency room (er) shortly after experiencing diaphragmatic stimulation.The physician suspected the lv lead to have been dislodged and may have caused the observed issues.Troubleshooting efforts were performed and the lv lead was successfully reprogrammed.No additional adverse patient effects were reported.The lv lead and crtd remains in service.

• Brand Name: VIGILANT 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: 18822943
• MDR Text Key: 336800808
• Report Number: 2124215-2024-12712
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526589287
• UDI-Public: 00802526589287
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/15/2024

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: G247
• Device Catalogue Number: G247
• Device Lot Number: 298599
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/16/2024
• Initial Date FDA Received: 03/01/2024
• Supplement Dates Manufacturer Received: 04/08/2024
• Supplement Dates FDA Received: 04/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/23/2023
• 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 Age: 58 YR
• Patient Sex: Female