MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VALITUDE X4 CRT-P; CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P)

Model Number U128

Device Problems Signal Artifact/Noise (1036); Over-Sensing (1438); Low impedance (2285)

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

Event Date 10/14/2022

Event Type  malfunction  

Event Description

It was reported that this pacemaker system delivered atrial tachy response (atr).Technical services reviewed the available electrograms, and it was determined that the atr episodes were inappropriate due to t-wave oversensing.Technical services provided reprogramming recommendations and the device was reprogramed.At this time, this pacemaker system remains in service and there were no adverse patient effects reported.Additional information was received which indicated that, the right atrial (ra) lead exhibited noisy signals oversensing that led into inappropriate atrs.Also, the ra lead exhibited low impedances within normal limits.This device remains in service.No adverse patient effects were reported.

• Brand Name: VALITUDE X4 CRT-P
• Type of Device: CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P)
• 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: 18143487
• MDR Text Key: 328199949
• Report Number: 2124215-2023-64407
• 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: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/15/2023

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: 04/18/2019
• Device Model Number: U128
• Device Catalogue Number: U128
• Device Lot Number: 720429
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/07/2023
• Initial Date FDA Received: 11/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2017
• 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: 97 YR
• Patient Sex: Female