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

Model Number U228

Device Problems Signal Artifact/Noise (1036); High impedance (1291); Over-Sensing (1438); Pacing Problem (1439); High Capture Threshold (3266)

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

Event Date 11/20/2023

Event Type  malfunction  

Event Description

It was reported that this cardiac resynchronization therapy pacemaker (crt-p) exhibited high right ventricular (rv) pacing threshold measurements and farfield oversensing of right atrial (ra) signals on the rv channel, causing pacing inhibition.Additionally, high out of range rv pacing impedance measurements of 2500 ohms and noisy signals that were not oversensed were identified.Boston scientific technical services (ts) provided reprogramming alternatives to avoid the reported observations and provided clarification to the physician about programming options and functionality per device design.Of note, the implanted rv lead, which is a non-boston scientific product, is positioned near the tricuspid valve, but the physician does not want to reposition it.No adverse patient effects were reported.The device remains in service.

Event Description

It was reported that this cardiac resynchronization therapy pacemaker (crt-p) exhibited high right ventricular (rv) pacing threshold measurements and farfield oversensing of right atrial (ra) signals on the rv channel, causing pacing inhibition.Additionally, high out of range rv pacing impedance measurements of 2500 ohms and noisy signals that were not oversensed were identified.Boston scientific technical services (ts) provided reprogramming alternatives to avoid the reported observations and provided clarification to the physician about programming options and functionality per device design.Of note, the implanted rv lead, which is a non-boston scientific product, is positioned near the tricuspid valve, but the physician does not want to reposition it.No adverse patient effects were reported.The device remains in service.

• Brand Name: VISIONIST 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: 18301355
• MDR Text Key: 330171268
• Report Number: 2124215-2023-70051
• Device Sequence Number: 1
• Product Code: NKE
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P030005/S138
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/28/2017
• Device Model Number: U228
• Device Catalogue Number: U228
• Device Lot Number: 703370
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2015
• 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: 77 YR