MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VALITUDE X4 CRT-P; IMPLANTABLE DEVICE

Model Number U128

Device Problems Over-Sensing (1438); High Capture Threshold (3266)

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

Event Date 11/29/2023

Event Type  malfunction  

Event Description

It was reported that there were high thresholds on the non-boston scientific left ventricular (lv) lead, and minute ventilation (mv) was turned off due to a signal artifact monitor (sam) event.The device and leads remain in service.No adverse patient effects were reported.

Manufacturer Narrative

This device has not been returned; therefore, technical analysis cannot be conducted.Investigation of the available information determined this device exhibited incorrect categorization of atrial arrhythmia(s) as mv noise.Please see the description field for more information regarding the specific circumstances of this event.

Event Description

It was reported that there were high thresholds on the non-boston scientific left ventricular (lv) lead, and minute ventilation (mv) was turned off due to a signal artifact monitor (sam) event.The device and leads remain in service.No adverse patient effects were reported.

• Brand Name: VALITUDE X4 CRT-P
• Type of Device: IMPLANTABLE DEVICE
• 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: 18288981
• MDR Text Key: 330012762
• Report Number: 2124215-2023-69758
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 00802526559402
• UDI-Public: 00802526559402
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030005/S113
• 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,Followup
• Report Date: 01/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/05/2021
• Device Model Number: U128
• Device Catalogue Number: U128
• Device Lot Number: 749038
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2020
• 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