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

Model Number G247

Device Problems High impedance (1291); Incorrect, Inadequate or Imprecise Result or Readings (1535); Failure to Convert Rhythm (1540)

Patient Problem Electric Shock (2554)

Event Date 06/27/2023

Event Type  Injury  

Event Description

It was reported that the cardiac resynchronization therapy defibrillators (crt-d) device was attempted implant due to shock impedance measurements greater than 125 ohms.During the device revision procedure, defibrillation threshold testing (dft) was performed, the patient had to be externally rescued due to the device displaying code 1005 and out of range shock impedances.Subsequently a new device was successfully implanted.No additional patient adverse effects were reported.

Manufacturer Narrative

The returned device was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.Visual examination of the device header and case noted minor scratches and tool marks on the case.Dimensional analysis of the header was completed.Each port measured as expected.The device was then exposed to simulated heart load conditions, pacing, and sensing functions were tested.Impedance testing was completed, and all measurements were within normal limits.The device operated appropriately with no interruptions in therapy output at the returned programmed settings.A series of electrical tests was also performed, and again, normal device function was observed.Analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.

Event Description

It was reported that the cardiac resynchronization therapy defibrillators (crt-d) device was attempted implant due to shock impedance measurements greater than 125 ohms.During the device revision procedure, defibrillation threshold testing (dft) was performed, the patient had to be externally rescued due to the device displaying code 1005 and out of range shock impedances.Subsequently a new device was successfully implanted.No additional patient adverse effects were reported.This device is expected to return for analysis.

• Brand Name: VIGILANT X4 CRT-D
• Type of Device: CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS (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: 17299534
• MDR Text Key: 318922495
• Report Number: 2124215-2023-36304
• 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: 02/16/2024

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: 300857
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/27/2023
• Initial Date FDA Received: 07/11/2023
• Supplement Dates Manufacturer Received: 02/15/2024
• Supplement Dates FDA Received: 02/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2023
• 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): Required Intervention; Hospitalization
• Patient Age: 63 YR
• Patient Sex: Male