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 Capture (1081); Over-Sensing (1438); Pacing Problem (1439); High Capture Threshold (3266)

Patient Problem Fall (1848)

Event Date 07/24/2020

Event Type  Injury  

Manufacturer Narrative

This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.Investigation of the available information determined this device exhibited oversensing of noise generated by the minute ventilation (mv)/ respiratory sensor that is related to a high impedance condition.Please see the description for more information regarding the specific circumstances of this event.This device was included in the recent minute ventilation sensor signal oversensing advisory population.

Event Description

It was reported that this patient experienced pacing inhibition resulting in asystole and collapsed at home.The patient was subsequently hospitalized and boston scientific technical services were contacted.It was discussed that a signal artifact monitoring (sam) episode had occurred due to oversensing of the minute ventilation (mv) feature signal from a competitor's lead.It was recommended to turn this mv feature off and perform provocative maneuvers to exclude lead impairment.At this time, the system remains implanted and in service.The patient was stable with no additional consequences 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: 10744220
• MDR Text Key: 213386915
• Report Number: 2124215-2020-22110
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 00802526559471
• UDI-Public: 00802526559471
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 10/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/21/2021
• Device Model Number: U228
• Device Catalogue Number: U228
• Device Lot Number: 739229
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/24/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/14/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1