MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VISIONIST X4 CRT-P; PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)

Model Number U228

Device Problems Failure to Read Input Signal (1581); Under-Sensing (1661)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/06/2020

Event Type  malfunction  

Manufacturer Narrative

As no further information regarding this event is expected, our investigation is complete.This report will be updated should additional information be provided.

Event Description

It was reported that this cardiac resynchronization therapy pacemaker (crt-p) was undersensing low amplitude atrial fibrillation signals.No changes were made and the crt-p remains in service.No adverse patient effects were reported.

• Brand Name: VISIONIST X4 CRT-P
• Type of Device: PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (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: 10616142
• MDR Text Key: 209582486
• Report Number: 2124215-2020-16086
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 00802526559471
• UDI-Public: 00802526559471
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: P030005/S138
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/01/2020

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: Lay User/Patient
• Device Expiration Date: 10/04/2020
• Device Model Number: U228
• Device Catalogue Number: U228
• Device Lot Number: 736386
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/06/2020
• Initial Date FDA Received: 10/01/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1