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

Model Number U225

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

Patient Problem Asystole (4442)

Event Date 05/12/2023

Event Type  malfunction  

Event Description

It was reported that the health care provider reached out to technical services (ts) to know if the electrocardiogram exhibited noise or ventricular tachycardia episode.Upon review, it was noted that this pacemaker triggered to lead safety switch suggesting high impedance out of range on the right ventricular (rv).Noise, oversensing, and pacing inhibition greater than 2 seconds were reported.Then the patient came into the clinic to troubleshoot, and it was noted that the patient had several computed tomography (ct).The sensitivity was adjusted and check the rv lead was recommended.Currently, this device remains in service and 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: 18209125
• MDR Text Key: 329003538
• Report Number: 2124215-2023-66762
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/15/2023
• Device Model Number: U225
• Device Catalogue Number: U225
• Device Lot Number: 720552
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2021
• 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: 74 YR
• Patient Sex: Male