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

Model Number G247

Device Problems Signal Artifact/Noise (1036); Failure to Capture (1081); High impedance (1291); Over-Sensing (1438); Pacing Problem (1439); Inappropriate/Inadequate Shock/Stimulation (1574); Under-Sensing (1661)

Patient Problems Electric Shock (2554); Unspecified Heart Problem (4454); Twiddlers Syndrome (4563)

Event Date 01/01/2023

Event Type  malfunction  

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) delivered inappropriate anti-tachycardia pacing (atp) and electric shocks.The patient reported experiencing palpitations.Boston scientific technical services (ts) was consulted and upon review, noise was noted on the right atrial (ra) lead, right ventricular (rv) lead and left ventricular (lv) lead.Out of range impedance measurements were noted on both the ra and lv leads.Undersensing, oversensing and loss of capture (loc) were also observed.Additional information confirmed a chest x ray was performed and a dislodgement of all three leads was confirmed.A lead revision procedure has been scheduled.No additional adverse patient effects were reported.At this time, this device system remains in service.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) delivered inappropriate anti-tachycardia pacing (atp) and electric shocks.The patient reported experiencing palpitations.Boston scientific technical services (ts) was consulted and upon review, noise was noted on the right atrial (ra) lead, right ventricular (rv) lead and left ventricular (lv) lead.Out of range impedance measurements were noted on both the ra and lv leads.Undersensing, oversensing and loss of capture (loc) were also observed.Additional information confirmed a chest x ray was performed and a dislodgement of all three leads was confirmed due to twiddler's syndrome.A revision procedure was performed and all three leads were explanted and replaced.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: 16372603
• MDR Text Key: 309512276
• Report Number: 2124215-2023-06562
• 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,Followup
• Report Date: 03/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/08/2024
• Device Model Number: G247
• Device Catalogue Number: G247
• Device Lot Number: 279501
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/21/2022
• 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
• Patient Age: 74 YR
• Patient Sex: Female