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

Patient Problem Cardiac Arrest (1762)

Event Date 01/27/2023

Event Type  Injury  

Event Description

It was reported that during an implant procedure, this new cardiac resynchronization therapy defibrillator (crt-d) was connected to the patient's previously implanted right ventricular (rv) lead, however no pacing was observed.The patient went into cardiac arrest and cardiopulmonary resuscitation was performed.The crt-d was disconnected from the rv lead and then reconnected; however, no pacing was still observed.A message was displayed on the programmer saying 'incompatible tachy mode: function disabled.' the crt-d was removed and replaced prior to pocket closure and was never in service.No additional adverse patient effects were reported.The crt-d is expected to be returned back from the field for analysis, this event will be updated upon completion of analysis.

• 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: 16299219
• MDR Text Key: 308820769
• Report Number: 2124215-2023-04713
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: TH
• 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: Physician
• Type of Report: Initial
• Report Date: 02/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2023
• 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: 291823
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention