MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VISIONIST X4 CRT-P; IMPLANTABLE PACEMAKER

Model Number U228

Device Problem Inaccurate Synchronization (1609)

Patient Problems Arrhythmia (1721); Dizziness (2194)

Event Date 01/17/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that this patient was admitted into clinical care due to recurrent pre-syncopal episodes.An echocardiography showed normal left ventricular function and device interrogation showed polymorphic ventricular tachycardia (vt).A boston scientific technical services (ts) consultant reviewed the stored electrograms and stated the available episodes showed the start of arrhythmia events during ambulatory right ventricular (rv) lead threshold tests.Ts recommended reprogramming the system parameters and the patient was prescribed beta-blocker medication.The treating physician elected to upgrade the therapy.As result, this cardiac resynchronization therapy pacemaker (crt-p) was replaced with a cardiac resynchronization therapy defibrillator (crt-d).No additional adverse patient effects were reported.

• Brand Name: VISIONIST X4 CRT-P
• Type of Device: IMPLANTABLE 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: 11669554
• MDR Text Key: 245514896
• Report Number: 2124215-2021-08105
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 00802526559471
• UDI-Public: 00802526559471
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P030005/S138
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/27/2017
• Device Model Number: U228
• Device Catalogue Number: U228
• Device Lot Number: 705536
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2015
• 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 Outcome(s): Hospitalization; Required Intervention