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

Model Number G247

Device Problems Pacing Problem (1439); Inappropriate/Inadequate Shock/Stimulation (1574); Inaccurate Synchronization (1609)

Patient Problems Ventricular Fibrillation (2130); Shock from Patient Lead(s) (3162)

Event Date 01/04/2024

Event Type  Injury  

Event Description

It was reported that the health care professional (hcp) called technical services (ts) and requested review of this cardiac resynchronization therapy defibrillator (crt-d) stored ventricular episodes.It was noted the patient does not have an implanted right atrial (ra) lead and may have received inappropriate atp therapy due to atrial fibrillation (af) with rapid ventricular response (rvr).Upon further review of the stored electrogram (egm), it was observed in the ventricular events, one of the episodes showed inappropriate atp therapy delivery appeared to have accelerated and induced the ventricular rhythm from ventricular tachycardia (vt) to a true ventricular fibrillation (vf) which was then converted with shock therapy.In the other ventricular episode, the vt rate zone was accelerated into the vf zone which led to inappropriate shock therapy to be delivered.The presenting egm was observed to have noisy signals in the left ventricular (lv) channel.Ts recommended for further device evaluation.The device remains in service.No additional adverse patient effects were reported.

• 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: 18554721
• MDR Text Key: 333389156
• Report Number: 2124215-2024-03059
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526589287
• UDI-Public: 00802526589287
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010012/S436
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/17/2023
• Device Model Number: G247
• Device Catalogue Number: G247
• Device Lot Number: 254820
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/04/2024
• Initial Date FDA Received: 01/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2021
• 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): Life Threatening
• Patient Age: 81 YR
• Patient Sex: Male