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

Model Number U128

Device Problems Signal Artifact/Noise (1036); Over-Sensing (1438); Pacing Problem (1439); Failure to Read Input Signal (1581)

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

Event Date 05/03/2023

Event Type  malfunction  

Event Description

It was reported that during a review of this cardiac resynchronization therapy pacemaker (crt-p), it was noted that the system had previously been configured to unipolar sensing.This configuration had resulted in episodes of pacemaker mediated tachycardia (pmt).Noise was recorded on both the right atrial and right ventricular channels, which use non-boston scientific leads, resulting in oversensing and inappropriate mode switching.This system was subsequently programmed to bipolar sensing which appeared to resolve the majority of issues.This crt-p had also recorded an alert due to low intrinsic amplitude on the rv channel.Device programming considerations were discussed.This system remains in service.No adverse patient effects were reported.

• Brand Name: VALITUDE X4 CRT-P
• Type of Device: CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR
• 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: 18555677
• MDR Text Key: 333497392
• Report Number: 2124215-2024-03080
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2018
• Device Model Number: U128
• Device Catalogue Number: U128
• Device Lot Number: 711217
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2016
• 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: 62 YR
• Patient Sex: Female