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

Model Number U128

Device Problems Failure to Read Input Signal (1581); Under-Sensing (1661)

Patient Problem Fall (1848)

Event Date 05/20/2023

Event Type  malfunction  

Event Description

It was reported that the patient with this implantable pacemaker arrived to the emergency room due to experiencing a fall.After this, the device was evaluated and it was found that it exhibited undersensing and low amplitude during an intrinsic ventricular fibrillation episode.A therapy upgrade procedure is being scheduled.At this time, this device remains in service.No further adverse patient effects were reported.

• Brand Name: VALITUDE 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: 17112708
• MDR Text Key: 317686181
• Report Number: 2124215-2023-30115
• 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
• Report Date: 06/12/2023

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 Expiration Date: 07/15/2022
• Device Model Number: U128
• Device Catalogue Number: U128
• Device Lot Number: 754367
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/23/2023
• Initial Date FDA Received: 06/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2020
• 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: 93 YR
• Patient Sex: Male