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

Model Number	U226
Medical Device Problem Codes	Signal Artifact/Noise (1036); Over-Sensing (1438); Pacing Problem (1439)
Health Effect - Clinical Code	Bradycardia (1751)
Date of Event	03/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the minute ventilation (mv) sensor of this pacemaker was disabled.Review of two signal artifact monitor (sam) episodes showed noise consistent with electromagnetic interference (emi).Impedance measurements were appropriate both before and after the sam episodes.There was no pacing inhibition as a result of the noise.Technical services discussed bringing the patient back into clinic as necessary to program mv back on.Further information was received that this pacemaker exhibited oversensing of noise on the right atrial (ra) lead resulting in pacing inhibition and inappropriate atrial tachy response (atr) episodes.Noise on the right ventricular (rv) lead was noted.The involved ra and rv leads are non boston scientific products.Additionally, oversensing on the left ventricular (lv) lead was suspected.No adverse patient effects were reported.This device remains in service.

• Brand Name: VISIONIST CRT-P
• Common Device Name: 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: 20546961
• Report Number: 2124215-2024-67466
• Device Sequence Number: 18025418
• Product Code: NKE
• UDI-Device Identifier: 00802526559457
• UDI-Public: 00802526559457
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P030005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/28/2024

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 03/15/2020
• Device Model Number: U226
• Device Catalogue Number: U226
• Device Lot Number: 700718
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2024
• Initial Report FDA Received Date: 10/28/2024
• Date Device Manufactured: 04/27/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Sex: Male