MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VIGILANT X4 CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D

Model Number G247

Device Problems Pacing Problem (1439); Inappropriate/Inadequate Shock/Stimulation (1574); Failure to Read Input Signal (1581); Under-Sensing (1661)

Patient Problem Shock from Patient Lead(s) (3162)

Event Date 02/23/2024

Event Type  Injury  

Event Description

It was reported that this patient with this biventricular (biv) implantable cardioverter defibrillator (icd) experienced atrial fibrillation (af) with rapid ventricular response (rvr) in multiple episodes.Anti-tachycardia pacing (atp) and shocks were provided which were noted to possibly have been from the af with rvr.Intermittent atrial undersensing was observed along with irregular ventricular to ventricular intervals.In one episode the atrial electrogram (egm) appeared almost flat with no atrial sensing.The shock channel morphology showed ventricular conduction.The p waves had been measuring higher than at implant.All lead measurements were within normal range.Technical services (ts) discussed programming optimization including adjusting the therapy zones, with the field representative who would discuss with the physician.This biv icd remains in service.No adverse patient effects were reported.

Manufacturer Narrative

If pertinent information is provided in the future, a supplemental report will be submitted.

• Brand Name: VIGILANT X4 CRT-D
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH 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: 18865280
• MDR Text Key: 337202509
• Report Number: 2124215-2024-14306
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2024
• 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: 297925
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/25/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2023
• 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
• Patient Age: 75 YR
• Patient Sex: Male