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

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 02/09/2024

Event Type  Injury  

Event Description

It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) experienced a ventricular tachycardia (vt) episode.The device delivered anti-tachycardia pacing (atp) which accelerated the rhythm into a faster vt.The device delivered electric shocks which induced the patient into ventricular fibrillation (vf).The third electric shock successfully converted the episode.No additional adverse patient effects were reported.At this time, this device remains in service.

Event Description

It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) experienced a ventricular tachycardia (vt) episode.The device delivered anti-tachycardia pacing (atp) which accelerated the rhythm into a faster vt.The device delivered electric shocks which induced the patient into ventricular fibrillation (vf).The third electric shock successfully converted the episode.Further information was received that this device delivered inappropriate anti-tachycardia pacing (atp) and one electric shock due to atrial fibrillation (af) with rapid ventricular response.Reprogramming options were discussed.No additional adverse patient effects were reported.At this time, this device remains in service.The complaint device was not returned to boston scientific, therefore, product analysis could not be performed.

• Brand Name: VIGILANT X4 CRT-D
• Type of Device: CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR
• 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: 18807226
• MDR Text Key: 336555109
• Report Number: 2124215-2024-12202
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 03/20/2024

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 Model Number: G247
• Device Catalogue Number: G247
• Device Lot Number: 309682
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/10/2024
• Initial Date FDA Received: 02/29/2024
• Supplement Dates Manufacturer Received: 03/14/2024
• Supplement Dates FDA Received: 03/20/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2023
• 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): Other; Life Threatening
• Patient Age: 87 YR
• Patient Sex: Male