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

Model Number U228

Device Problems Pacing Problem (1439); Under-Sensing (1661)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/13/2023

Event Type  malfunction  

Event Description

It was reported that this implantable pacemaker exhibited undersensing and overpacing due to the programing of the device.Additionally, the minute ventilation (mv) rate was not as expected.Reprograming of the device was discussed.This device remains in service.No further adverse patient effects were reported.

Event Description

It was reported that this implantable pacemaker exhibited undersensing and overpacing due to the programing of the device.Additionally, the minute ventilation (mv) rate was not as expected.Reprograming of the device was discussed.This device remains in service.No further adverse patient effects were reported.

Manufacturer Narrative

This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.Investigation of the available information determined that the minute ventilation (mv) sensor in this device has the potential to increase the pacing rate to the maximum sensor rate more quickly than expected.As a result, a software update was released in 2013 that reduced the minimum mv response factor settings and re-distributed the remaining mv response factors to provide a consistent change in sensor rate across the range of mv response factors.This corrective action is expected to reduce, but not eliminate the occurrence of this behavior.

• 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: 16891863
• MDR Text Key: 314820819
• Report Number: 2124215-2023-22438
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/14/2023

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 Model Number: U228
• Device Catalogue Number: U228
• Device Lot Number: 780520
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/16/2023
• Initial Date FDA Received: 05/08/2023
• Supplement Dates Manufacturer Received: 05/25/2023
• Supplement Dates FDA Received: 06/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2022
• 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: 87 YR
• Patient Sex: Male