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); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Electric Shock (2554)

Event Date 09/12/2023

Event Type  Injury  

Event Description

It was reported that the right ventricular (rv) lead had been exhibiting gradually increasing shock impedance measurements, up to 150 ohms.The physician performed a commanded 1.1 joule shock test for a lead evaluation, which initially displayed a measurement of 89 ohms, which then rose back up to 132 ohms.The physician attempted to deliver a 41 joule shock, but the implantable device declared a code 1005, indicating an open circuit condition.The patient was hospitalized pending a lead revision procedure, in which the rv lead will be surgically capped.It was stated that due to the device's recent implant and long amount of remaining longevity, the device would be left in-service.At this time, the system remains implanted and the patient is stable, but hospitalized pending the procedure.

• 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: 17822320
• MDR Text Key: 324320219
• Report Number: 2124215-2023-52895
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: P010012/S436
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/26/2023

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 Expiration Date: 10/15/2022
• Device Model Number: G247
• Device Catalogue Number: G247
• Device Lot Number: 247622
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/12/2023
• Initial Date FDA Received: 09/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization