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); Failure to Read Input Signal (1581)

Patient Problem Dizziness (2194)

Event Date 04/15/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the patient implanted with this cardiac resynchronization therapy pacemaker (crt-p) experienced episodes of vertigo and dizziness, related to possible loss of capture during bi-ventricular pacing.The field representative reported that this was a known issue for this patient and the clinic believed it was related to the change in sensitivity gain due to previous high amplitude sensed beats.A request was made for technical services to review the device data and episodes in the remote monitoring system to better understand the issue.No adverse patient effects were reported.Technical services reviewed the available data and noted that capture appeared to be present even though the right ventricular (rv) and left ventricular (lv) electrograms seemed almost flat.It was noted that the rv signal after an rv paced beat was low, but there was a common pattern that could be seen after each of the pacing events.The rv paced signal is so small due to the high rv sensed signal (according to lead trends many times it was over 25mv).This happens in all of available episodes because in all of them there is at least one sensed beat, which generates a bigger signal detected in the rv that, consequently, makes the gain adapt to it and leaves the rv signal after rv pacing very small in comparison.To verify capture, they could bring the patient in to the clinic for a programmer interrogation and to perform a threshold test.The gains can be adjusted and the amplitudes can be measured.Technical services was not able to confirm the cause of the patient's symptoms with a review of the available data.

• 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: 12250634
• MDR Text Key: 264270823
• Report Number: 2124215-2021-22107
• Device Sequence Number: 1
• Product Code: NKE
• 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: 07/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2021
• 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: 754062
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/24/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1