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

Model Number U225

Device Problems Signal Artifact/Noise (1036); Failure to Capture (1081); Over-Sensing (1438); Pacing Problem (1439); Off-Label Use (1494); Under-Sensing (1661); High Capture Threshold (3266)

Patient Problem Asystole (4442)

Event Date 12/18/2023

Event Type  malfunction  

Event Description

It was reported that this cardiac resynchronization therapy pacemaker (crt-p) system had shown right ventricular (rv) lead noise in the past, and the rv lead and the left ventricular (lv) lead ports were switched.During recent generator change, device measurements were tested, and it was identified that when not switched, cross chamber blanking, and pacing inhibition in the original lv lead were noted.During system evaluation, the original rv lead, now in the lv port was exhibiting loss of capture at high capture thresholds.In addition, when using the correct intended port, asystole was experienced.Reprogramming options were discussed.This crt-p system remains in service.No additional adverse patient effects were reported.

• Brand Name: VISIONIST CRT-P
• Type of Device: CARDIAC RESYNCHRONIZATION THERAPY 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: 18465588
• MDR Text Key: 332397148
• Report Number: 2124215-2024-00595
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 00802526559426
• UDI-Public: 00802526559426
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030005/S138
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/08/2024

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: Health Professional
• Device Model Number: U225
• Device Catalogue Number: U225
• Device Lot Number: 727507
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2023
• 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: 98 YR
• Patient Sex: Female