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

Model Number G247

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Edema (1820); Tachycardia (2095)

Event Date 05/08/2020

Event Type  Injury  

Manufacturer Narrative

As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.

Event Description

It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) experienced vibration.Additional information obtained from the field representative that patient was first seen in clinic without device issues and eventually presented to emergency department as patient was again experiencing vibrating sensation and fast heart rate.Moreover, patient was then admitted to the hospital for an immediate device interrogation and noted lower extremity edema.Thus, medications were increased.This device 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: 10227572
• MDR Text Key: 197604430
• Report Number: 2124215-2020-10911
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526589287
• UDI-Public: 00802526589287
• 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: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/26/2021
• Device Model Number: G247
• Device Catalogue Number: G247
• Device Lot Number: 230195
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/08/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/11/2019
• 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): Hospitalization
• Patient Age: 76 YR