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 Pacing Problem (1439); Under-Sensing (1661)

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

Event Date 05/04/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that electrogram (egm) review was requested for this cardiac resynchronization therapy pacemaker (crt-p) system.Upon review of a stored pacemaker mediated tachycardia (pmt) episode, sinus tachycardia with biventricular (biv) pacing followed by a farfield or retrograde p-wave was observed.The retrograde or farfield signal was larger than the p-wave and every other beat fell into blanking.After the pmt termination algorithm, a 2:1 atrial arrhythmia is clearly revealed.It was noted that the auto gain control (agc) may impact egm scaling.A ventricular episode was stored, however the onset and end of the episode were not included in the egm.The field representative and health care professional (hcp) discussed that this appears to be a new onset atrial arrhythmia.Distinguishing between ventricular tachycardia (vt) with retrograde and supraventricular tachycardia (svt) is not possible, and rhythm interpretation is at the physician's discretion.This crt-p system 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: 17026658
• MDR Text Key: 316194673
• Report Number: 2124215-2023-27340
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 00802526559471
• UDI-Public: 00802526559471
• 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: 05/30/2023

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: 07/07/2022
• Device Model Number: U228
• Device Catalogue Number: U228
• Device Lot Number: 754084
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/04/2023
• Initial Date FDA Received: 05/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/23/2020
• 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: 76 YR
• Patient Sex: Female