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

Model Number G247

Device Problems Signal Artifact/Noise (1036); High impedance (1291); Over-Sensing (1438); Pacing Problem (1439)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/22/2020

Event Type  malfunction  

Event Description

It was reported that review of an atrial tachy response (atr) episode noted this cardiac resynchronization therapy defibrillator (crt-d) and a non-boston scientific right atrial (ra) lead exhibited noise.The noise was not initially sensed and then was oversensed and subsequent pacing at the maximum tracking rate was observed, which, spontaneously broke.Additionally, intermittent increases in pacing impedance measurements in the 500 ohms range were observed.Technical services (ts) discussed potential electromagnetic interference (emi) or oversensing related to the respiratory rate trend (rrt) feature and discussed the option of programming the rrt feature off.Ts assisted a health care professional (hcp) in turning rrt off.No adverse patient effects were reported.This product remains in service.

• 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: 11042531
• MDR Text Key: 222762573
• Report Number: 2124215-2020-21603
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/24/2020
• Device Model Number: G247
• Device Catalogue Number: G247
• Device Lot Number: 198660
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/22/2020
• Initial Date FDA Received: 12/18/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2018
• 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 Age: 64 YR