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

Model Number G247

Device Problems High impedance (1291); Failure to Convert Rhythm (1540); Patient-Device Incompatibility (2682)

Patient Problem Electric Shock (2554)

Event Date 12/11/2023

Event Type  Injury  

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) system recorded a high out of range shock impedance measurement.Boston scientific technical services (ts) reviewed the device data and confirmed the out of range measurement.It was also discussed that all lead trends are showing initial variability and then stabilization.Further review of the crt-d system was recommended, and troubleshooting options were provided.The patient attended an in-clinic follow-up.The physician identified that the crt-d appears to be low in position and have some adipose tissue below the device, energy distribution was likely impacted by this reason.Induction testing was performed in-clinic.In the first attempt there was no ventricular fibrillation (vf) induction, on the second attempt the vf was induced and the shock delivered, however the shock was not effective and the vf terminated two seconds after the shock delivery.On the third attempt with reverse shock polarity the shock was not effective and an external shock was required to return the patient back to normal sinus rhythm.The shock impedance alert was increased to 150 ohms.Ts discussed possible options with the health care professional (hcp), however, there is no further action planned at this time.The crt-d system remains in service.No additional adverse patient effects were reported.

• 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: 18411305
• MDR Text Key: 331526803
• Report Number: 2124215-2023-74227
• Device Sequence Number: 1
• Product Code: NIK
• 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: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2023
• 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: 299366
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Hospitalization; Required Intervention