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

Model Number U225

Device Problems Signal Artifact/Noise (1036); Over-Sensing (1438)

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

Event Date 10/06/2023

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that this cardiac resynchronization therapy pacemaker (crt-p) has recorded atrial lead noise that is over sensed.For the overall system, the sensing, impedance and threshold measurements are within normal limits.Automatic pace threshold test episodes stored in configured collection period were successful.The crt-p remains in service at this time.No 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: 18017706
• MDR Text Key: 326698571
• Report Number: 2124215-2023-59890
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: U225
• Device Catalogue Number: U225
• Device Lot Number: 722753
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/05/2022
• 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: 101 YR
• Patient Sex: Female