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); High impedance (1291); Over-Sensing (1438)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/20/2019

Event Type  malfunction  

Manufacturer Narrative

This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.The associated investigation determined that this device exhibited intermittent impedance measurements with no conclusive evidence of a malfunction or inadequate lead-to-device connection; please refer to the description for more information regarding the specific circumstances of this event.

Event Description

It was reported that this cardiac resynchronization therapy pacemaker (crt-p) and associated non-boston scientific right atrial (ra) and right ventricular (rv) leads exhibited high, out-of-range pacing impedance measurements on the rv lead, with loss of capture (loc) also observed.The ra lead was oversensing ventricular activity, resulting in inappropriate atrial tachy response (atr) episodes.It was reported both leads had triggered the lead safety switch (lss) in the past.The ra lead was left in the unipolar configuration and the rv lead was reprogrammed to bipolar and the lss was programmed off.Now, however, the rv lead was intentionally reprogrammed to unipolar to obtain in-range pacing impedance measurements and normal threshold values.The sensitivity on the ra lead was decreased to mitigate oversensing the rv activity.A new remote follow-up was planned, where data was to be reviewed to ensure these programming changes were effective.The device and competitors leads remain 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: 10021481
• MDR Text Key: 189753272
• Report Number: 2124215-2020-09856
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/19/2018
• Device Model Number: U228
• Device Catalogue Number: U228
• Device Lot Number: 709710
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1