MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VISIONIST X4 CRT-P; IMPLANTABLE PACEMAKER

Model Number U228

Device Problems Signal Artifact/Noise (1036); Failure to Capture (1081); Over-Sensing (1438); Pacing Problem (1439)

Patient Problem Asystole (4442)

Event Date 09/28/2023

Event Type  malfunction  

Event Description

It was reported that this implantable pacemaker exhibited noise, oversensing, loss of capture and pacing inhibition on the right ventricular and right atrial channels.It was determined that this was due to electromagnetic interference (emi).Further evaluation of the patient was discussed.This device remains in service.No further adverse patient effects were reported.

• Brand Name: VISIONIST X4 CRT-P
• Type of Device: IMPLANTABLE PACEMAKER
• 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: 18257680
• MDR Text Key: 329619513
• Report Number: 2124215-2023-68475
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 00802526559471
• UDI-Public: 00802526559471
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030005/S138
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/18/2020
• Device Model Number: U228
• Device Catalogue Number: U228
• Device Lot Number: 735997
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2018
• 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: 78 YR
• Patient Sex: Male